Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Official notice

Original summary

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A 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. 1) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027; 2) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25FBD161; 3) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBN454; 4) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBG142; 5) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBE995; 6) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25DBE771; 7) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25CBB549; 8) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBS071; 9) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBB895; 10) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24FBK537; 11) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24CBK339; 12) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24ABH890; 13) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 23KBA331; 14) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 22KBD675 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 108 units