Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination
Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.
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: FDA Class II recall with potential endotoxin contamination in surgical kit components. No illnesses or injuries reported per source text; the hazard is theoretical. Meets criteria for score 3: risk-of-harm medical device product where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 973,785 Presource Kits (laryngoscopy packs, Catalog Number SRIET0979N) distributed worldwide, including nationwide in the United States, Canada, and Saudi Arabia.
The recall is due to potential endotoxin contamination in non-sterile surgical strips and patties included in these kits. Endotoxins are bacterial contaminants that may cause adverse reactions if introduced into the body during medical procedures.
Affected lots include: J4219A, J4678M, J53W13, J6277W, J7904P, J8491U, J6785Z, J6786D, J9602P, J96A00, J96N37, 5136008, 5405613, and PO351726.
Healthcare providers and facilities should stop using affected kits immediately and contact Cardinal Health 200, LLC for instructions on product return or disposal.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kit
- 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) SRIET0979N
- UDI-DI:10885425517206 (each) 50885425517204 (case)
- Lot Number: J4219A
- 2) SRIET0979N
- Lot Number: J4678M
- 3) SRIET0979N
- Lot Number: J53W13
- 4) SRIET0979N
- Lot Number: J6277W
- 5) SRIET0979N
- Lot Number: J7904P
- 6) SRIET0979N
- Lot Number: J8491U
- 7) SRIET0979N
- Lot Number: J6785Z
- 8) SRIET0979N
- Lot Number: J6786D
- 9) SRIET0979N
- Lot Number: J9602P
- 10) SRIET0979N
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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