Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.
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 recall involves a high-risk pathogen (endotoxin) in surgical medical devices. The source indicates 'potential' contamination with no reported illnesses or injuries. Per the rubric, high-risk pathogens without reported illness are scored as High (3).
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Presource surgical kits, including nasal, septoplasty, ear, and sinus models. A total of 512,786 units were distributed to healthcare facilities in the US, Canada, and Saudi Arabia.
The kits contain non-sterile surgical strips and patties that may be contaminated with endotoxin, a bacterial toxin that could cause serious adverse reactions if introduced during surgical procedures.
Healthcare facilities and consumers who have these kits should discontinue use. Anyone who has had a surgical procedure using these kits should consult with their healthcare provider if they experience any complications.
The recalled product
- Product
- Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 512,786
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)
- Catalog Number PE23NSMEA
- UDI/DI 10197106461914 (EA)50197106461912 (CS)
- Lot Number 6928769
- Lot Number 7160527
- Lot Number 7163103
- Lot Number 7280105
- Catalog Number PE23NSMEC
- UDI/DI 10197106644829 (EA)50197106644827 (CS)
- Lot Number 7332911
- Lot Number 7332915
- Catalog Number PE23SENLA
- UDI/DI 10197106543351 (EA)50197106543359 (CS)
- Lot Number 7160537
- Lot Number 7331341
- Lot Number 7332910
- Catalog Number PE23SENLC
- UDI/DI 10197106760956 (EA)50197106760954 (CS)
- Lot Number 7332917
- Catalog Number PE30EAGT6
- UDI/DI 10195594668167 (EA)50195594668165 (CS)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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