Recall Z-1136-2025
Cardinal Health 200, LLC · initiated November 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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…
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-1136-2025
- Initiated
- November 8, 2024
- Posted by FDA
- February 10, 2025
- Product code
- OJK – Eye Tray
- Quantity
- 973,785 total units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1126-2025 Class II | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1127-2025 Class II | Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1128-2025 Class II | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2)…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1129-2025 Class II | Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1130-2025 Class II | Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1131-2025 Class II | Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1132-2025 Class II | Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1133-2025 Class II | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1134-2025 Class II | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1135-2025 Class II | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2)…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |
| Z-1137-2025 Class II | Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 11/08/2024Open, Classified |