Device product
Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
Z-1120-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 72,624 units
- Official record key
device-enforcement:Z-1120-2024
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 DYND06002, UDI/DI 40080196816645 (case), 10080196816644 (unit), Lot Numbers: 2022041290, 2022051090, 2022062090, 2022081190, 2022081790, 2022101990, 2022102090, 2022111490, 2023050390, 2023050890, 2023042890, 2023050490, 2023063090, 2023062990, 2023070390, 2023072890, 2023082590
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility