Medline Industries, LP: Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBND

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 distribution - US Nationwide. Quantity: 59 units Lot/code info: 1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521

UPC codes

10193489479294, 40193489479295, 10193489880816, 40193489880817, 10193489478549, 40193489478540, 10193489478457, 40193489478458, 10193489880823, 40193489880824

Source

Official record: FDA (Device enforcement) ↗

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