B.Braun Medical, Inc.

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	—	—	—	5	2025-07-24
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	—	—	—	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	—	—	—	1	2020-03-05

Date	Severity	Status	Recall #	Product	Code	Reason
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…

Clearance cadence by quarter

Product codes worked

Recalls (241)

All 510(k) clearances (19)

Date	K-number	Device	Code	Class	Specialty
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	—	—
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	—	—
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	—	—
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	—	—
2021-10-25	K213085	Introcan Safety 3 Closed IV Catheter	FOZ	Class II	General Hospital
2021-09-24	K202618	IV Administration Sets	FPA	—	—
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	—	—
2020-03-05	K193101	Omnifix Low Dead Space Luer Lock Syringe	FMF	—	—