Reported Aug 9, 2017 · Terminated
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Greatbatch Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575
Is this the product you have?
ViaPeel PTFE Peelable Introducer 5FRPart Number 10890-006
- Lot codes and dates
- Lot NumberW3101005
- Amount recalled
- 5,000 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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