Medline Industries, LP: Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Details from the source

Reason for recall: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Distribution: US Nationwide distribution. Quantity: 1720 units Lot/code info: 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), L

UPC codes

10193489467642, 40193489467643

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.