Medline Industries, LP: Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691

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: 753 units Lot/code info: 1) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABK325; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABX057; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21DBB713; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBE305; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBS122; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR275; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR277; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21IBU128; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21JBJ227; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21WBA902; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABD970; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABM691; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBM867; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897

UPC codes

10193489478839, 40193489478830, 10193489897890, 40193489897891, 10195327534141, 40195327534142

Source

Official record: FDA (Device enforcement) ↗

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