FDA-Device2017-08-09Class II
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
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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