Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

Official notice

Original summary

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108 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) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 5) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 6) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 7) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 8) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 9) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086; 10) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 779 units