Device product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Z-0638-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 66 units
- Official record key
device-enforcement:Z-0638-2025
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 DYNJ80686A, UDI/DI 10195327560645 (each) 40195327560646 (case), Lot Numbers: 24CBR604, 24CBA831; 2) REF DYNJ84667, UDI/DI 10195327396329 (each) 40195327396320 (case), Lot Numbers: 23KBO980
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.