Medline Industries, LP: Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934

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: 6961 units Lot/code info: 1) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23ABN008; 2) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23CBM469; 3) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23EBH500; 4) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23GBE369; 5) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBE051; 6) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBU695; 7) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23KBD600; 8) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23LBC152; 9) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24ABR800; 10) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24CBC183; 11) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24DBS738; 12) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24FBN230; 13) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24HBB532; 14) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 15) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 16) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23LBJ521; 17) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886

UPC codes

10193489455885, 40193489455886, 10193489294606, 40193489294607, 10193489398885, 40193489398886, 10193489448917, 40193489448918, 10884389206669, 40884389206660, 10193489901399, 40193489901390, 10888277538023, 40888277538024, 10193489729306, 40193489729307, 10193489398632, 40193489398633, 10193489422887, 40193489422888, 10889942494675, 40889942494676, 10193489249460, 40193489249461

Source

Official record: FDA (Device enforcement) ↗

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