Z-0627-2025 Class II Ongoing
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
- 980 units
Product Description
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691
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 DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824; 2) REF DYNJ0842590G, UDI/DI 10195327286439 (each) 40195327286430 (case), Lot Numbers: 23HDA481, 23DDB914, 23DDA319; 3) REF DYNJ41473G, UDI/DI 10193489983982 (each) 40193489983983 (case), Lot Numbers: 22KMD254, 23KBD038, 23EMK120, 23CMA828; 4) REF DYNJ41473I, UDI/DI 10195327584931 (each) 40195327584932 (case), Lot Numbers: 24DBF911; 5) REF DYNJ44148G, UDI/DI 10195327412487 (each) 40195327412488 (case), Lot Numbers: 23EBV384, 23JBW504, 23KBG481; 6) REF DYNJ81776A, UDI/DI 10195327515881 (each) 40195327515882 (case), Lot Numbers: 23LBN724, 24CBH515; 7) REF DYNJ82691, UDI/DI 10195327202934 (each) 40195327202935 (case), Lot Numbers: 23GMI494, 23JMH927