Device product
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Z-1133-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 528 units
- Official record key
device-enforcement:Z-1133-2024
Official wording
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Code information: REF TC7170, UDI/DI 50653160043629 (case), 00653160043624 (unit), Lot Numbers: 2022042790, 2022121290, 2023031790, 2023042490; 2023092190
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility