Device product
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D
Z-0647-2025
Product summary
- Event
- Event 95621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 478 units
- Official record key
device-enforcement:Z-0647-2025
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 CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI/DI 10195327451295 (each) 40195327451296 (case), Lot Numbers: 23JBF512, 23IBQ647; 3) REF CDS985431L, UDI/DI 10195327527273 (each) 40195327527274 (case), Lot Numbers: 24ABA205, 24ABW239, 24ABV349, 24CBR704, 24EBP485; 4) REF DYNJ44153G, UDI/DI 10195327412623 (each) 40195327412624 (case), Lot Numbers: 23KBB932; 5) REF DYNJ60924C, UDI/DI 10195327470333 (each) 40195327470334 (case), Lot Numbers: 23JBF913; 6) REF DYNJVB1280C, UDI/DI 10195327173951 (each) 40195327173952 (case), Lot Numbers: 23ELB178, 23CLA196, 23BLA668, 23BLA272; 7) REF DYNJVB1280D, UDI/DI 10195327482114 (each) 40195327482115 (case), Lot Numbers: 24CLA257, 23LLA915, 24CLA715, 24BLA712;
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.