—#211611

Product

Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected 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 Number: J46C10 ; 18) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot Number: J6372Z ; 19) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J79Z51 ; 20) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: N/A ; 21) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J8393Z ; 22) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J6372Z ; 23) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6702038 ; 24) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6788692 ; 25) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6806122 ; 26) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005495 ; 27) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005496 ; 28) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7160517 ; 29) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7331480 ; 30) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 31) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 32) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333446 ; 33) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7360541 ; 34) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J87C82 ; 35) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J8998P ; 36) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5140388 ; 37) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J6935J ; 38) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5533344 ; 39) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 40) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 41) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J65K19 ; 42) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664115 ; 43) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 44) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5918342 ; 45) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251073 ; 46) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 47) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251076 ; 48) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6345528 ; 49) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6701855 ; 50) SEY35OPBLX, UDI-DI:10888439516173 (each) 50888439516171 (case), Lot Number: J28W65 ; 51) SEY35OPBLY, UDI-DI:10888439586558 (each) 50888439586556 (case), Lot Number: J4220A ; 52) SEY35OPBLZ, UDI-DI:10888439611519 (each) 50888439611517 (case), Lot Number: J4220A ;

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Timeline

Recall initiated: 2024-11-08
Posted by FDA: 2025-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.