Device product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Z-1137-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 120 units
- Official record key
device-enforcement:Z-1137-2024
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 MNS4360, UDI/DI 10653160141716 (case), 00653160141719 (unit), Lot Numbers: 2022091690, 2022112290, 2022120990
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility