Device product
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
Z-0624-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1271 units
- Official record key
device-enforcement:Z-0624-2025
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 DYNJ39185D, UDI/DI 10195327157166 (each) 40195327157167 (case), Lot Numbers: 22GBA088, 22FBS934, 22HBA086; 2) REF DYNJ44997J, UDI/DI 1019532738093 (each) 40195327380930 (case), Lot Numbers: 23GBU050, 23KBI422, 23JBL004, 23IBB532, 23LBK392, 24BBA287, 24CBM430; 3) REF DYNJ58409C, UDI/DI 10193489957242 (each) 40193489957243 (case), Lot Numbers: 22GBT985, 22LBD309, 23JBP407; 4) REF DYNJ66252A, UDI/DI 10193489887853 (each) 40193489887854 (case), Lot Numbers: 22OBL262; 5) REF DYNJ909591, UDI/DI 10195327413613 (each) 40195327413614 (case), Lot Numbers: DYNJ909591
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.