Device product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Z-0622-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-0622-2025
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 DYNJ85691, UDI/DI 10195327534141 (each) 40195327534142 (case), Lot Numbers: 24ABR853; 2) REF DYNJ902123J, UDI/DI 10195327497453 (each) 40195327497454 (case), Lot Numbers: 23JDB498, 24DDA877, 24CDB678, 24BDB737
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.