Medline Industries, LP: Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBN

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: 29192 Lot/code info: 1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 401934894

UPC codes

10198459565748, 40198459565749, 10193489477405, 40193489477406, 10193489478716, 40193489478717, 10193489477757, 40193489477758, 10195327660017, 40195327660018, 10195327435219, 40195327435210, 10195327570545, 40195327570546, 10193489338454, 40193489338455, 10195327558116, 40195327558117, 10198459421297, 40198459421298, 10193489346084, 40193489346085, 10193489865905, 40193489865906, 10195327191733, 40195327191734, 10195327425258, 40195327425259, 10198459329517, 40198459329518, 10195327139544, 40195327139545, 10193489588576, 40193489588577, 10193489220759, 40193489220750, 10193489803488, 40193489803489, 10889942670512, 40889942670513

Source

Official record: FDA (Device enforcement) ↗

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