Device product
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Z-0636-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-0636-2025
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: REF DYNJ52141B, UDI/DI 10195327028459 (each) 40195327028450 (case), Lot Numbers: 23FMA347, 23JBS200
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.