Device product
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Z-1093-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1093-2024
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 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 2022022550, 2022050550, 2022051050
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility