Device product
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
Z-0153-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 320 units
- Official record key
device-enforcement:Z-0153-2025
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: a) DYNJ80370A, UDI/DI 40195327388547 (each), 10195327388546 (case), Lot Numbers: 23LBM330; b) DYNJRA1854A, UDI/DI 40195327117062 (each), 10195327117061 (case), Lot Numbers: 23LBJ089
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