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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 973,785
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.
Part of a larger recall action
This product is one of 12 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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