FDAFDA · Food and drugs·Recall number Z-2781-2017
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Published August 9, 2017 · Recall initiated: November 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Greatbatch Medical
- Distributor
- NY
- Lot
- Lot Number: W3101005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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