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) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
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.