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FDA (Device enforcement)Recalled 2024-11-08class ii

Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY EN

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) SEY30EYRVA, UDI-DI:10195594159382 (each) 50195594159380 (case), Lot Number: 5140378 ; 2) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 5970335 ; 3) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 6133661 ; 4) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6701854 ; 5) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6702035 ; 6) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7266056 ; 7) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280113 ; 8) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280116 ; 9) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7320241 ; 10) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331349 ; 11) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331352 ; 12) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332924 ; 13) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332923 ; 14) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6025793 ; 15) SEY35OP961, UDI-DI:10888439702651 (each) 50888439702659 (case), Lot Number: J46C12 ; 16) SEY35OP962, UDI-DI:10888439769005 (each) 50888439769003 (case), Lot Number: J4220A ; 17) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot

UPC codes

10195594159382, 50195594159380, 10195594555771, 50195594555779, 10195594759735, 50195594759733, 10888439702651, 50888439702659, 10888439769005, 50888439769003, 10888439626698, 50888439626696, 10888439867541, 50888439867549, 10888439984903, 50888439984901, 10888439516173, 50888439516171, 10888439586558, 50888439586556, 10888439611519, 50888439611517

Source

Official record: FDA (Device enforcement)

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

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