FDA-Device2017-08-09Class II
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Greatbatch Medical
Hazard
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Sold states
NY
Affected count
5,000 devices
Manufactured in
2300 Berkshire Ln N, N/A, Plymouth, MN, United States
Products
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2017Don't want to check this manually?
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