Device product
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Z-0642-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 336 units
- Official record key
device-enforcement:Z-0642-2025
Official wording
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Code information: 1) REF DYNJ0531985R, UDI/DI 10195327216405 (each) 40195327216406 (case), Lot Numbers: 22HMF853, 23CMA603, 22LMG691; 2) REF DYNJ0843760I, UDI/DI 10195327365141 (each) 40195327365142 (case), Lot Numbers: 23DDA645; 3) REF DYNJ0843760J, UDI/DI 10195327491369 (each) 40195327491360 (case), Lot Numbers: 23JDA821
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.