BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2781-2017 · Initiated November 11, 2016

    Recall

    Recall Number
    Z-2781-2017
    Event Number
    76701
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 11, 2016
    Terminated
    November 3, 2017
    Address
    2300 Berkshire Ln N, Plymouth, MN, 55441-4575

    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.

    Action

    Consignee was sent via email on 11/11/2016 a Greatbatch "Urgent Medical Device Recall" letter dated November 2016. The letter described the product involved in the recall, Reason for Field Corrective Action, Risk to Health, Replacement Devices & Instructions to Customer. Advised consignees to quarantine the product, contact end users & complete and return the Field Recall Response Form to Stericycle at [email protected] or fax at 888-473-8015. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at [email protected]

    Distribution

    NY

    Quantity

    5,000 devices