Device product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Z-0632-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-0632-2025
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 DYNJ81597, UDI/DI 10195327124007 (each) 40195327124008 (case), Lot Numbers: 22IBF254, 23BBO299
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.