Cardinal Health Presource ACDF Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling Presource ACDF surgical kits for potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses or injuries have been reported.
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 involving potential endotoxin contamination in surgical supplies. Since no illnesses or injuries have been reported and the hazard remains theoretical, the severity is High per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cardinal Health 200, LLC is recalling Cardinal Health Presource ACDF surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties included in the kits. The affected kits carry catalog numbers SNEHBACSCA and SNEHBACSCB, with lot numbers J6935H and J65K18.
Endotoxin is a bacterial contamination that could pose a health risk in surgical applications. No illnesses or injuries have been reported to date related to this recall.
The recalled kits were distributed worldwide, including to the United States, Canada, and Saudi Arabia. A total of 973,785 units are affected by this Class II recall.
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 Kits
- Hazard
- endotoxin
- 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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