BEUDAMED
    FDA Enforcement Class II Terminated

    ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

    Recall: Z-2781-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2781-2017
    Event ID
    76701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greatbatch Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 9, 2017
    Initiation Date
    November 11, 2016
    Classification Date
    July 29, 2017
    Termination Date
    November 3, 2017
    Address
    2300 Berkshire Ln N, N/A, Plymouth, MN, 55441-4575, United States

    Description

    ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

    Reason

    Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

    Code Info

    Lot Number: W3101005

    Distribution

    NY

    Quantity

    5,000 devices