FDA recall Z-2781-2017
Greatbatch Medical · Class II · device
Product
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Reason for recall
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Distribution
NY
Key facts
- Status
- Terminated
- Initiation date
- 2016-11-11
- Report date
- 2017-08-09
- Termination date
- 2017-11-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plymouth, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2017