Device product
Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
Z-1109-2024
Product summary
- Event
- Event 93800
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 139 units
- Official record key
device-enforcement:Z-1109-2024
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 DYNJ56344B, UDI/DI 40889942612322 (case), 10889942612321 (unit), Lot Numbers: 22CLA043, 22HLA191, 22ILA180, 23BLA030, 23BLB019, 23ELA630; b) REF DYNJ62803, UDI/DI 40193489688994 (case), 10193489688993 (unit), Lot Numbers: 22GBS133, 23GBF930
Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Derived failure modes
-
Sterility assurance
lack of sterility