Cardinal Health Presource Kits recalled for endotoxin contamination risk
Cardinal Health is recalling certain Presource ACDF Kits due to potential endotoxin contamination in non-sterile surgical strips and patties used in spinal fusion 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 an FDA Class II recall involving a high-risk biological contaminant (endotoxin) in sterile surgical supplies with potential for serious infection if contaminated product contacts internal tissue. The source text does not report any actual illnesses or injuries, making this a theoretical risk scenario that qualifies as High per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling Cardinal Health Presource ACDF Kits with catalog numbers SNEHBACSCA (lot J6935H) and SNEHBACSCB (lot J65K18). These surgical kits contain non-sterile surgical strips and patties that may be contaminated with endotoxin, a bacterial toxin that can cause adverse reactions when it comes into contact with sterile internal tissue during spinal fusion procedures.
The affected products were distributed worldwide, including throughout the United States, Canada, and Saudi Arabia. A total of 973,785 units are involved in this recall.
Patients who have received spinal fusion procedures using these kits should consult their healthcare provider if they experience signs of infection or other complications. Healthcare facilities should identify and quarantine remaining inventory of the affected lot numbers and contact their Cardinal Health representative for return instructions.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
- 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 (6)
- 1) ACDF PACK
- UDI-DI:10195594353926 (each) 50195594353924 (case)
- Lot Number: J6935H
- 2) ACDF PACK
- UDI-DI:10195594439880 (each) 50195594439888 (case)
- Lot Number: J65K18
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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