Device product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Z-0175-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 197 units
- Official record key
device-enforcement:Z-0175-2025
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) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers: 24ABG207; b) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers: 23LBN531; c) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers: 23LBL712; d) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers: 24ABR224
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