Device product
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Z-2593-2025
Product summary
- Event
- Event 97495
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 88 units
- Official record key
device-enforcement:Z-2593-2025
Official wording
Reason: Convenience kits labeled as sterile have not gone through the sterilization process.
Code information: 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686
Distribution pattern: US Distribution to States of: FL, MD, NJ, TN
Derived failure modes
-
Unknown
Convenience kits labeled as sterile have not gone through the sterilization process.