Device product
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Z-1120-2023
Product summary
- Event
- Event 91483
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 981 units
- Official record key
device-enforcement:Z-1120-2023
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 DYNDC2733, GTIN 40888277783974, Lot # 22HMG957; b) Reorder number SUT14640, GTIN 40653160184158, Lot # 22HMG490
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.