Greatbatch Medical recalls ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- Recall date
- November 11, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2781-2017
- FDA classification
- Class II
- Brand / firm
- Greatbatch Medical
- Sold / distributed
- NY
Why it was recalled
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
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