FDAClass IIMarch 21, 2018

Left Atrial Catheter Set recall

Left Atrial Catheter Set

Why was Left Atrial Catheter Set recalled?

Label does not state that the product is heparin-coated.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS

Product
Left Atrial Catheter Set
Recalling firm
Cook Inc.
Quantity
56
Distribution
Nationally
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls