BEUDAMED
    FDA Recall Terminated

    Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex Medical, Bannockburn, IL 60015 USA, Made in UK

    Recall: Z-0244-2007 · Initiated October 31, 2006

    Recall

    Recall Number
    Z-0244-2007
    Event Number
    36788
    Firm
    Teleflex Medical
    FEI Number
    3004959265
    Product Code
    BYW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2006
    Posted
    December 5, 2006
    Terminated
    November 30, 2007
    Address
    2345 Waukegan Rd, Ste 120, Bannockburn, IL, 60015-1580

    Description

    Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex Medical, Bannockburn, IL 60015 USA, Made in UK

    Reason

    Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.

    Action

    Teleflex Medical sent Urgent Medical Device Recall letters dated 10/31/06 via UPS overnight to the direct accounts, informing them that the product was incorrectly labeled as a 1 liter bag when the correct volume of the bag is liter, and requesting that they cease use of the affected units and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

    Distribution

    Nationwide including the states of California and Florida

    Quantity

    50 bags