FDAClass IIFebruary 19, 2025

Cardinal Health Presource Kits: 1) ACDF PACK recall: Endotoxin

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

Why was Cardinal Health Presource Kits: 1) ACDF PACK recalled?

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;

Product
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Recall date
February 19, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls