FDAClass IIAugust 9, 2017

ViaPeel PTFE Peelable Introducer 5FR recall

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Why was ViaPeel PTFE Peelable Introducer 5FR recalled?

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

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 Number: W3101005

Product
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Recalling firm
Greatbatch Medical
Quantity
5,000 devices
Distribution
NY
Recall date
August 9, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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