FDAClass IINovember 6, 2019

Cordis MAXI LD PTA Dilatation Catheter recall

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

Why was Cordis MAXI LD PTA Dilatation Catheter recalled?

Product was manufactured utilizing an expired inner body.

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 Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020

Product
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Recalling firm
Cordis Corporation
Quantity
21 units
Distribution
US distribution to AL, AZ, FL, MN, and MO
Recall date
November 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls