Chrysalis Intelligence · Sponsors · Nurse Assist, LLC

Nurse Assist, LLC

Haltom City, TX, US · 1 510(k) clearances · 5 recalls (5 Class I)

Total clearances
1
2020-08-11 → 2020-08-11
Last 12 months
0
Product codes
1
Most recent
2020-08-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NGT Saline, Vascular Access Flush Class II General Hospital 1 2020-08-11
Safety

Recalls (5)

Class I (serious)
5
Risk of injury / death
Total recalls
5
Currently ongoing
5
Most recent
2023-11-06
DateSeverityStatusRecall # ProductCodeReason
2023-11-06 Class I Ongoing Z-0515-2024 Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILL… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh…
2023-11-06 Class I Ongoing Z-0514-2024 Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh…
2023-11-06 Class I Ongoing Z-0513-2024 Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh…
2023-11-06 Class I Ongoing Z-0512-2024 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh…
2023-11-06 Class I Ongoing Z-0511-2024 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV F… Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, wh…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-08-11 K201286 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch NGT Class II General Hospital