Z-1845-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1720 units
Product Description
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Reason for Recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Distribution Pattern
US Nationwide distribution.
Code Information
1) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21CBJ477; 2) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBE184; 3) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBJ527; 4) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21HBL388; 5) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21IBT013; 6) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21LBS718; 7) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22BBD935; 8) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22CBA262; 9) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22FBM910; 10) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22LBQ838; 11) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23FBS838; 12) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23IBD099; 13) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23KBA057; 14) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24ABJ743; 15) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24EBG776; 16) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24FBC225; 17) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24IBW215; 18) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24LBU055; 19) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22HBG782; 20) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 25DBP554