Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,

Hazard

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Details from the source

Reason for recall: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. Quantity: 973,785 total units Lot/code info: 1) PB23DFCM3, UDI-DI:10888439587050 (each) 50888439587058 (case), Lot Number: J37U13 ; 2) PB23DFCM4, UDI-DI:10888439601053 (each) 50888439601051 (case), Lot Number: J37U14 ; 3) PB23DFCM5, UDI-DI:10888439641790 (each) 50888439641798 (case), Lot Number: J46C08 ; 4) PB23DFCM6, UDI-DI:10888439836172 (each) 50888439836170 (case), Lot Number: J6050A ; 5) PB23DFCM7, UDI-DI:10888439853087 (each) 50888439853085 (case), Lot Number: J7704J ; 6) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J4952P ; 7) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J53W77 ; 8) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J5679N ; 9) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J84K06 ; 10) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J85W31 ; 11) PE40HNAJ10, UDI-DI:10195594746513 (each) 50195594746511 (case), Lot Number: 5918338 ; 12) PE40HNAJ11, UDI-DI:10195594777685 (each) 50195594777683 (case), Lot Number: 6279857 ; 13) PE40HNAJ12, UDI-DI:10195594808051 (each) 50195594808059 (case), Lot Number: 5649225 ; 14) PE40HNAJ13, UDI-DI:10195594878672 (each) 50195594878670 (case), Lot Number: 6279859 ; 15) PE40HNAJ14, UDI-DI:10197106057902 (each) 50197106057900 (case), Lot Number: 6487892 ; 16) PE40HNAJ15, UDI-DI:10197106116449 (each) 50197106116447 (case), Lot Number: 6487896 ; 17) PE40HNAJ16, UDI-DI:10197106138632 (each) 50197106138630 (case), Lot Number: 5 ; 18) P

UPC codes

10888439587050, 50888439587058, 10888439601053, 50888439601051, 10888439641790, 50888439641798, 10888439836172, 50888439836170, 10888439853087, 50888439853085, 10887488531298, 50887488531296, 10195594746513, 50195594746511, 10195594777685, 50195594777683, 10195594808051, 50195594808059, 10195594878672, 50195594878670, 10197106057902, 50197106057900, 10197106116449, 50197106116447, 10197106138632, 50197106138630, 10197106224205, 50197106224203, 10197106480168, 50197106480166, 10197106571453, 50197106571451, 10197106587300, 50197106587308, 10195594142469, 50195594142467, 10195594240776, 50195594240774, 10195594358556, 50195594358554

Source

Official record: FDA (Device enforcement) ↗

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