BEUDAMED
    FDA Recall Terminated

    HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

    Recall: Z-0020-2011 · Initiated August 10, 2010

    Recall

    Recall Number
    Z-0020-2011
    Event Number
    56536
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    GBS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 10, 2010
    Posted
    October 7, 2010
    Terminated
    April 22, 2016
    Address
    5 Wentworth Dr, Hudson, NH, 03051

    Description

    HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132

    Reason

    Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.

    Action

    Atrium Medical isued Product Recall Notice letters dated August 10, 2010 to customers, identifying the affected product and actions to be taken by customers. Customers were instructed to remove the affected products from inventory and return them to Atrium, and complete and fax a recall notice acknowledgement to Atriuim at 603-821-1420. Customers can contact Atrium at 800 528-7486, x5350 (Joe DePaolo) or x5351 (Karen Hall) for further information.

    Distribution

    Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.

    Quantity

    1 case, 10/case