FDAClass IIMarch 18, 2020

Cordis POWERFLEX P3 recall

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Why was Cordis POWERFLEX P3 recalled?

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

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?

Lot 82155955, Use by date 2021-06-30

Product
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Recalling firm
Cordis Corporation
Quantity
89 units
Distribution
US and UK
Recall date
March 18, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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