Device product
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Z-1109-2023
Product summary
- Event
- Event 91483
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-1109-2023
Official wording
Reason: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Code information: GTIN 10193489720594, Lot # 22EBA798
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.