Device product
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Z-0172-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 144 units
- Official record key
device-enforcement:Z-0172-2025
Official wording
Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Code information: UDI/DI 40195327198153 (each), 10195327198152 (case), Lot Numbers: 23LBO804
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Derived failure modes
-
Sterility assurance
sterile product if the vendor seal of the pouch is opened/unsealed