Device product
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Z-1090-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 385028 trays
- Official record key
device-enforcement:Z-1090-2024
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: UDI/DI 40888277597922 (case), 10888277597921 (unit), Lot Numbers: 22DBO136, 22EBE146, 22HBP422, 22IBN508, 22IBS920, 22KBS241, 23BBE594, 23CBN979, 23EBT594, 23IBA884
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility