Chrysalis Intelligence · Sponsors · B.Braun Medical, Inc.

B.Braun Medical, Inc.

Center Valley, PA, US · 20 510(k) clearances · 242 recalls (15 Class I)

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Total clearances
20
2020-03-05 → 2026-09-10
Last 12 months
2
Product codes
10
Most recent
2026-09-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II General Hospital 7 2026-05-15
FPA Set, Administration, Intravascular Class II General Hospital 5 2025-07-24
LJH System, Irrigation, Urological Class II Gastroenterology, Urology 1 2026-09-10
DTK Filter, Intravascular, Cardiovascular Class II Cardiovascular 1 2024-07-31
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact Class II General Hospital 1 2024-07-13
BSO Catheter, Conduction, Anesthetic Class II Anesthesiology 1 2023-09-15
FIP Subsystem, Water Purification Class II Gastroenterology, Urology 1 2023-08-16
LHI Set, I.V. Fluid Transfer Class II General Hospital 1 2020-12-09
GBM Catheter, Urethral Class II Gastroenterology, Urology 1 2020-05-07
FMF Syringe, Piston Class II General Hospital 1 2020-03-05
Safety

Recalls (242)

Class I (serious)
15
Risk of injury / death
Total recalls
242
Currently ongoing
216
Most recent
2026-08-04
DateSeverityStatusRecall # ProductCodeReason
2026-08-04 Class II Ongoing Z-3089-2026 Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025 — Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
2026-05-06 Class I Ongoing Z-2278-2026 Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C… — These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary re…
2026-05-06 Class I Ongoing Z-2277-2026 Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B… — These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary re…
2026-05-06 Class I Ongoing Z-2276-2026 Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867… — These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary re…
2026-03-19 Class I Ongoing Z-1803-2026 B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19 Class I Ongoing Z-1802-2026 B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19 Class I Ongoing Z-1801-2026 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19 Class I Ongoing Z-1800-2026 B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19 Class I Ongoing Z-1799-2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-03-19 Class I Ongoing Z-1798-2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. — Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
2026-02-02 Class II Ongoing Z-1483-2026 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product De… — The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02 Class II Ongoing Z-1482-2026 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A… — The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02 Class II Ongoing Z-1481-2026 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version… — The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2025-10-29 Class II Ongoing Z-0718-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0717-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0716-2026 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0715-2026 Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0714-2026 ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0713-2026 SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spac… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0712-2026 SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0711-2026 SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0710-2026 RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0709-2026 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0708-2026 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0707-2026 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0706-2026 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0705-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0704-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0703-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0702-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0701-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0700-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0699-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0698-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0697-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0696-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0695-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0694-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0693-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0692-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0691-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0690-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0689-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0688-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0687-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0686-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0685-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0684-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0683-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0682-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0681-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0680-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0679-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0678-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0677-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0676-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0675-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0674-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0673-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0672-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0671-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0670-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0669-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0668-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0667-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0666-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0665-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0664-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0663-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0662-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0661-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0660-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0659-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0658-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0657-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0656-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0655-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0654-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0653-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0652-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0651-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0650-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0649-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0648-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0647-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0646-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0645-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0644-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0643-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0642-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0641-2026 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0640-2026 Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0639-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0638-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0637-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0636-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0635-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0634-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0633-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0632-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0631-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0630-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0629-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0628-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0627-2026 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0626-2026 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0625-2026 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0624-2026 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0623-2026 CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0622-2026 Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0621-2026 Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0620-2026 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0619-2026 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0618-2026 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0617-2026 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0616-2026 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0615-2026 B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0614-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0613-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0612-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0611-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0610-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0609-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0608-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0607-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0606-2026 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0605-2026 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0604-2026 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29 Class II Ongoing Z-0603-2026 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar… — Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-09-30 Class I Ongoing Z-0070-2026 Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20… — The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
2025-09-18 Class II Ongoing Z-0126-2026 Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD J… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0125-2026 Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga.… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0124-2026 Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0123-2026 Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0122-2026 ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN … — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0121-2026 PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PER… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0120-2026 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0119-2026 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0118-2026 PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. … — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0117-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0116-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0115-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged an… — Potential for the lid of the catheter connector to be in the incorrect position.
2025-09-18 Class II Ongoing Z-0114-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and … — Potential for the lid of the catheter connector to be in the incorrect position.
2025-07-09 Class I Ongoing Z-2176-2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. — Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not in…
2025-02-17 Class II Ongoing Z-1397-2025 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. — Increased risk for valve housing detachment causing leakage.
2024-12-04 Class II Ongoing Z-1021-2025 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal … — Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is…
2024-08-15 Class II Ongoing Z-3179-2024 STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during … — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3178-2024 STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae… — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3177-2024 STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model… — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3176-2024 STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during … — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3175-2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi… — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3174-2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi… — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion…
2024-08-15 Class II Ongoing Z-3173-2024 SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod… — Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion …
2024-08-08 Class II Ongoing Z-3144-2024 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number… — Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
2024-08-07 Class I Ongoing Z-2972-2024 Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U — Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge d…
2024-06-17 Class II Ongoing Z-2404-2024 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2403-2024 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2402-2024 Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2401-2024 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV)… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2400-2024 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) … — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2399-2024 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) a… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2398-2024 Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV)… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2397-2024 Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2396-2024 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administra… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2395-2024 Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2394-2024 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2393-2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2392-2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2391-2024 Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV)… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2390-2024 Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) … — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2389-2024 Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2388-2024 Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) … — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2387-2024 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) admin… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2386-2024 Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) … — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2385-2024 Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2384-2024 Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2383-2024 Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) … — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2382-2024 Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2381-2024 Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2380-2024 Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2379-2024 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) a… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2378-2024 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) adm… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2377-2024 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-17 Class II Ongoing Z-2376-2024 OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o… — Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and th…
2024-06-14 Class II Ongoing Z-2437-2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Pro… — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal H…
2024-06-14 Class II Ongoing Z-2436-2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P… — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal H…
2024-06-14 Class II Ongoing Z-2435-2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description… — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal H…
2024-06-14 Class II Ongoing Z-2434-2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Softwar… — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal H…
2024-06-14 Class II Ongoing Z-2433-2024 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product D… — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal H…
2024-05-17 Class II Ongoing Z-2134-2024 Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17 Class II Ongoing Z-2133-2024 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17 Class II Ongoing Z-2132-2024 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17 Class II Ongoing Z-2131-2024 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. — The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-01-22 Class II Ongoing Z-1150-2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device… — Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the…
2024-01-22 Class II Ongoing Z-1149-2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass… — Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the …
2023-11-01 Class I Ongoing Z-0355-2024 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3… — In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, whi…
2023-09-26 Class II Ongoing Z-0136-2024 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0135-2024 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0134-2024 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0133-2024 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-… — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0132-2024 TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0131-2024 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0130-2024 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0129-2024 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-26 Class II Ongoing Z-0128-2024 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution conta… — Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose bo…
2023-09-21 Class I Ongoing Z-0124-2024 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System — Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to…
2023-09-21 Class I Ongoing Z-0123-2024 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System — Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to…
2023-08-07 Class II Ongoing Z-2644-2023 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metere… — The sterile blister packaging may be damaged, and sterility may be compromised
2023-08-07 Class II Ongoing Z-2643-2023 B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dos… — The sterile blister packaging may be damaged, and sterility may be compromised
2023-07-31 Class II Ongoing Z-2627-2023 Perifix¿ / Epidural anesthesia set, medicated — Product may be mislabeled with an incorrect lid stock label.
2023-06-05 Class II Ongoing Z-2003-2023 Design Options¿ / Epidural anesthesia kit (10 count carton) — Kits were assembled with the incorrect Filter Straw.
2023-06-05 Class II Ongoing Z-2002-2023 Perifix¿ / Epidural anesthesia kit (10 count carton) — Kits were assembled with the incorrect Filter Straw.
2022-09-15 Class II Ongoing Z-0092-2023 CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve int… — The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The is…
2022-09-15 Class II Ongoing Z-0091-2023 Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended … — The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may re…
2022-09-15 Class II Ongoing Z-0090-2023 ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free acce… — The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may r…
2022-09-01 Class II Ongoing Z-0009-2023 Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arteri… — Potential for leakage at the catheter hub.
2022-02-07 Class II Terminated Z-0819-2022 PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made s… — Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion …
2022-01-31 Class II Terminated Z-0727-2022 Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiratio… — This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the d…
2022-01-28 Class II Terminated Z-0873-2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Articl… — Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in…
2022-01-28 Class II Terminated Z-0872-2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Articl… — Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in…
2021-08-10 Class II Terminated Z-2560-2021 Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion … — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2559-2021 Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2558-2021 Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2557-2021 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT … — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2556-2021 OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosin…
2021-08-10 Class II Terminated Z-2555-2021 PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump f… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosin…
2021-08-10 Class II Terminated Z-2554-2021 OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infu… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2553-2021 Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT P… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2552-2021 OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosin…
2021-08-10 Class II Terminated Z-2551-2021 V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infu… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2550-2021 ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2549-2021 Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System … — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2548-2021 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Hor… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2547-2021 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or … — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosin…
2021-08-10 Class II Terminated Z-2546-2021 Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety In… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2545-2021 Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System a… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-08-10 Class II Terminated Z-2544-2021 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Hor… — Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing…
2021-06-25 Class II Terminated Z-2137-2021 Infusomat Space Volumetric Pump Administration Set, Product Code 490100 — There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on sc…
2021-03-15 Class II Terminated Z-1509-2021 Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: Th… — BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
2020-11-23 Class II Terminated Z-0719-2021 APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascul… — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o…
2020-11-23 Class II Terminated Z-0718-2021 APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascul… — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o…
2020-11-23 Class II Terminated Z-0717-2021 APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascul… — There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o…
Filings

All 510(k) clearances (20)

Date K-number Device Code Class Specialty
2026-09-10 K254111 Irrigation/Urology Sets LJH Class II Gastroenterology, Urology
2026-05-15 K253235 Introcan Safety® Deep Access XL IV Catheter FOZ Class II General Hospital
2025-07-24 K243392 Infusomat® Space Volumetric Infusion Pump Administration Sets FPA Class II General Hospital
2024-07-31 K240578 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System DTK Class II Cardiovascular
2024-07-26 K241845 Introcan Safety® 2 IV Catheter FOZ Class II General Hospital
2024-07-13 K241385 Omnifix Syringe NRFit QEH Class II General Hospital
2023-09-15 K231242 Perifix FX Catheter; Contiplex FX Catheter BSO Class II Anesthesiology
2023-08-16 K223479 AQUAbase nX FIP Class II Gastroenterology, Urology
2022-06-23 K220756 Introcan Safety 2 IV Catheter FOZ Class II General Hospital
2022-05-14 K220626 Introcan Safety IV Catheter FOZ Class II General Hospital
2022-03-03 K213778 IV Administration Set FPA Class II General Hospital
2022-02-11 K213664 B. Braun Introcan Safety 2 IV Catheter FOZ Class II General Hospital
2022-01-18 K212842 Microvolume Luer Access Device FPA Class II General Hospital
2021-10-25 K213085 Introcan Safety 3 Closed IV Catheter FOZ Class II General Hospital
2021-09-24 K202618 IV Administration Sets FPA Class II General Hospital
2020-12-09 K201469 Mini Spike Plus 6/8R LHI Class II General Hospital
2020-05-07 K192577 Actreen Hi-Lite Intermittent Urinary Catheters GBM Class II Gastroenterology, Urology
2020-04-01 K192676 Introcan Safety 2 IV Catheter 18-24 gauge FOZ Class II General Hospital
2020-03-19 K191658 IV Sets not made with PVC FPA Class II General Hospital
2020-03-05 K193101 Omnifix Low Dead Space Luer Lock Syringe FMF Class II General Hospital
Data source: openFDA · Generated 2026-09-23 11:01 · Last ingest 2026-09-23T15:00:49.349277 · Pipeline: Chrysalis Intelligence