Z-1388-2026 Class II Ongoing

Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G

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) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 2) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 3) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 4) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 5) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 6) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 7) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 8) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 9) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 10) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 11) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 12) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 13) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 14) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 15) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 16) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 17) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 18) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 19) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 20) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067