Device product
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE KIT, Reorder Number PT235A
Z-1128-2023
Product summary
- Event
- Event 91483
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4779 units
- Official record key
device-enforcement:Z-1128-2023
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: a) Reorder Number DYNJ67850, GTIN 10193489445541, Lot # 22BBJ239; b) Reorder Number DYNJSHOULDER2, GTIN 10884389097458, Lot # 22DBN344; c) Reorder Number P429589A, GTIN 40889942436348, Lot # 22HME367; d) Reorder Number SPEC0177, GTIN 40884389914657, Lot # 22MBA770; e) Reorder Number PT235A, GTIN 40653160992746, Lot # 22HMH321
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.