Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall involving potential endotoxin contamination in surgical products. No incidents of illness or injury are reported in the source material. Under the severity rubric, potential contamination with high-risk pathogens in medical devices without reported harm qualifies as High severity.
Plain-English summary
Cardinal Health Presource Kits are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties included in the products. The kits have been distributed worldwide, with approximately 973,785 units distributed to the United States, Canada, and Saudi Arabia.
Healthcare facilities that have received these products should be aware of this potential contamination issue and take appropriate action regarding any affected inventory.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical kits
- Hazard
- endotoxin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) CHIP99NC12
- UDI-DI:10195594105471 (each) 50195594105479 (case)
- Lot Number: J8692J
- 2) CHIP99NC13
- UDI-DI:10195594202378 (each) 50195594202376 (case)
- Lot Number: 5138245
- 3) CHIP99NC14
- UDI-DI:10195594276898 (each) 50195594276896 (case)
- Lot Number: 5324036
- 4) CHIP99NC15
- UDI-DI:10195594399696 (each) 50195594399694 (case)
- Lot Number: 5530905
- 5) CHIP99NC16
- UDI-DI:10195594444846 (each) 50195594444844 (case)
- Lot Number: 5530911
- 6) CHIP99NC17
- UDI-DI:10197106046159 (each) 50197106046157 (case)
- Lot Number: 6560930
- 7) CHIP99NC18
- UDI-DI:10197106169643 (each) 50197106169641 (case)
Distribution
Distributed nationwide across the United States.
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