Device product
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Z-2592-2025
Product summary
- Event
- Event 97495
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 22 units
- Official record key
device-enforcement:Z-2592-2025
Official wording
Reason: Convenience kits labeled as sterile have not gone through the sterilization process.
Code information: 1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;
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.