Z-3295-2026 Class II Ongoing

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2 ; 2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2 ; 3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2 ; 4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2 ; 5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2 ; 6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2 ; 7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Lot Number: 25217FG2 ; 8) PGCGLCB11, UDI-DI: 10198956116177(each), 50198956116175(case), Lot Number: 24355FG2 ; 9) PV63CMST5, UDI-DI: 10198956526204(each), 50198956526202(case), Lot Number: 25148FG2 ; 10) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 11) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24325FG2 ; 12) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 13) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25029FG2 ; 14) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 15) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25045FG2 ; 16) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 17) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 18) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25085FG2 ; 19) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: 25217FG2 ; 20) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25217FG2 ; 21) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25216FG2 ; 22) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25274FG2 ; 23) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24325FG2 ; 24) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24309FG2 ; 25) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 26) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24348FG2 ; 27) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 28) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 29) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 30) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 31) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 32) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 33) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 34) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 35) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ; 36) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 37) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 38) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 39) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 40) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 41) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 42) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 43) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25069FG2 ; 44) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 45) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25161FG2 ; 46) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 47) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25101FG2 ; 48) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25121FG2 ; 49) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 50) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24353FG2 ; 51) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ; 52) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 53) SLC37LCJ21, UDI-DI: 10198956035850(each), 50198956035858(case), Lot Number: 24317FG2 ; 54) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24317FG2 ; 55) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24348FG2 ; 56) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24353FG2 ; 57) SMA30RBHSA, UDI-DI: 10198956437067(each), 50198956437065(case), Lot Number: 25274FG2