Z-0624-2025 Class II Ongoing
FDA device recall Z-0624-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on October 9, 2024 and is designated Class II. Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. The recall status is ongoing. Affected quantity: 1271 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1271 units
Product Description
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
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
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