BEUDAMED
    FDA Recall Terminated

    Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

    Recall: Z-1070-2012 · Initiated December 12, 2011

    Recall

    Recall Number
    Z-1070-2012
    Event Number
    60828
    Firm
    Benlan, Inc.
    FEI Number
    3932
    Product Code
    KYX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 12, 2011
    Posted
    February 21, 2012
    Terminated
    March 19, 2013
    Address
    2760 Brighton Road, Oakville Canada

    Description

    Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

    Reason

    The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.

    Action

    The firm initiated their recall of the specified lots of product in November, 2011 by sending a "Customer/Distributor Medical Device Correction" letter to their consignee. The letter requested they examine their inventory, quarantine any affected product and complete a verification and response form to be returned to the firm. Questions were directed to (905) 829-5004 ext 233.

    Distribution

    Nationwide Distribution, USA - including only the state of Pennsylvania

    Quantity

    143,250