Device product
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Z-0637-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 486 units
- Official record key
device-enforcement:Z-0637-2025
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 CDS983465N, UDI/DI 10195327497309 (each) 40195327497300 (case), Lot Numbers: 24CDB460, 24BDA880, 23KDB948; 2)REF CDS983465N, UDI/DI 10195327699987 (each) 40195327699988 (case), Lot Numbers: 24EDB092, 24EDA519; 3) REF DYNJ63331D, UDI/DI UDI/DI 10195327270346 (each) 40195327270347 (case), Lot Numbers: 23LME440, 23HMI168, 23KMD370
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.