Cardinal Health Presource ACDF Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling Presource ACDF surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected lot numbers are J6935H and J65K18.
What this means for you
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 of surgical kits with potential endotoxin contamination. No illnesses or injuries have been reported in the source text. Because the hazard is serious but no actual harm has been documented, the severity score is 3 (High).
Plain-English summary
Cardinal Health 200, LLC is recalling two Presource ACDF Surgical Kits (catalog numbers SNEHBACSCA and SNEHBACSCB) due to potential endotoxin contamination in the non-sterile surgical strips and patties included in these kits.
Endotoxins are bacterial contaminants that can trigger serious adverse reactions in patients. The potential for endotoxin contamination in surgical components used during procedures poses a risk to patient safety.
Approximately 973,785 units have been distributed worldwide, including throughout the United States, Canada, and Saudi Arabia. The affected units bear lot numbers J6935H and J65K18, identifiable by UDI-DI codes 10195594353926 (catalog SNEHBACSCA) and 10195594439880 (catalog SNEHBACSCB).
Healthcare facilities and providers should discontinue use of affected kits and contact Cardinal Health for instructions regarding return or replacement. If adverse events have occurred following use of these kits, consult your healthcare provider and report the incident to Cardinal Health.
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
- Category
- Medical Device — Surgical Kit
- Hazard
- endotoxin
- bacterial-contamination
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.
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