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.
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
1) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 22LDA486; 2) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDA474; 3) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDB552; 4) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392; 5) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 23HDB637; 6) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDA984; 7) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB327; 8) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB829; 9) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24DDB769; 10) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24EDB468; 11) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24FDB302; 12) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24GDB922; 13) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24IDB525; 14) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24KDB955; 15) DYNJVB91109D, UDI-DI: 10198459514838(each), 40198459514839(case), Lot Number: 25LLA489
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.