Device product
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
Z-1135-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 576 units
- Official record key
device-enforcement:Z-1135-2024
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: a) REF ST11670A, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers: 2022042590, 2022111690, 2023020690, 2023040690, 2023063090, 2023091390,
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility