BEUDAMED
    FDA Recall Terminated

    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    Recall: Z-0366-2017 · Initiated September 29, 2016

    Recall

    Recall Number
    Z-0366-2017
    Event Number
    75302
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 29, 2016
    Terminated
    April 5, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    Reason

    Added Instructions for Use: After application, inspect the Light Glove for barrier integrity

    Action

    Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888

    Distribution

    Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom

    Quantity

    4950 units