Device product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Z-0169-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-0169-2025
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 40195327108084 (each), 10195327108083 (case), Lot Numbers: 23LBL738
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