FDAClass INovember 15, 2023

Cordis Angiographic Catheterization Sets recall: Sterility Concern

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Why was Cordis Angiographic Catheterization Sets recalled?

Non-sterile product labeled as sterile was distributed.

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?

UDI/DI 10705032025935, Lot Number 18223410

Product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Recalling firm
Cordis US Corp
Quantity
30 devices
Distribution
US Distribution to: OK
Recall date
November 15, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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