Medline Industries, LP: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Details from the source

Reason for recall: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. Distribution: Worldwide - US Nationwide distribution. Quantity: 13025 units Lot/code info: 1) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 17) DYK1011945P, UDI-DI: 10884389389973(each), 408843

UPC codes

10884389389973, 40884389389974

Source

Official record: FDA (Device enforcement) ↗

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