Cardinal Health Presource Kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in 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: FDA Class II recall with no reported illnesses or injuries. Endotoxin contamination in surgical supplies is a serious biological hazard, but the recall involves only potential contamination without documented adverse events, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health has initiated a recall of Presource Kits containing surgical strips and patties due to potential endotoxin contamination. The recall affects six lot numbers across three catalog numbers (PN76LMM14, PN76LMMD9, PN76LMMDX).
Endotoxins are bacterial compounds that can cause adverse reactions including fever and potentially serious systemic effects if introduced into the body during surgery. The affected products are classified as non-sterile, and endotoxin contamination represents a potential infection risk in surgical settings.
Approximately 973,785 units were distributed worldwide to healthcare facilities in the United States, Canada, and Saudi Arabia. The recalled lot numbers are J8241D, J79Z55, J4220A, J4220D, J4953F, and J46C13.
Healthcare facilities should immediately discontinue use of affected lots. Users should identify units using the provided catalog numbers and lot numbers, quarantine affected supplies, and contact Cardinal Health for guidance on returns or replacement products.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
- Manufacturer
- Cardinal Health 200, LLC
- 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 (15)
- 1) PN76LMM14
- UDI-DI:10888439914467 (each) 50888439914465 (case)
- Lot Number: J8241D
- 2) PN76LMM14
- Lot Number: J79Z55
- 3) PN76LMMD9
- UDI-DI:10888439651416 (each) 50888439651414 (case)
- Lot Number: J4220A
- 4) PN76LMMD9
- Lot Number: J4220D
- 5) PN76LMMDX
- UDI-DI:10888439401318 (each) 50888439401316 (case)
- Lot Number: J4953F
- 6) PN76LMMDX
- Lot Number: J46C13
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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