Device product
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Z-0180-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-0180-2025
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 40889942863304 (each), 10889942863303 (case), Lot Numbers: 24ABA894
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