Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108

Reason: 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.

Code information: 1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23AMG574; 5) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMA829; 6) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMI776; 7) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23EMH095; 8) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23FMI704; 9) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23HMC628; 10) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23IMC652; 11) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 12) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 13) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24IMG516; 14) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 15) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 16) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 17) DYNJRA1979B, UDI-DI: 10198459371950(each), 40198459371951(case), Lot Number: 25FBG333; 18) DYNJRA2608, UDI-DI: 10198459331640(each), 40198459331641(case), Lot Number: 25ELB099; 19) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381; 20) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086

Distribution pattern: Worldwide - US Nationwide distribution.