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

Official notice

Original summary

Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691 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) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21DBB713; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABX057; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABK325; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 23CBN841; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22LBK911; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22KBH787; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22HBQ099; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBX191; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBF305; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBR042; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBM224; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBM867; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABM691; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABD970; 18) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21WBA902; 19) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21JBJ227; 20) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21IBU128; 21) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR277; 22) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR275; 23) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBS122; 24) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBE305; 25) DYNJ85691, UDI-DI: 10195327534141(each), 40195327534142(case), Lot Number: 24ABR853 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 753 units