BEUDAMED
    FDA Recall Terminated

    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance

    Recall: Z-1609-2014 · Initiated March 19, 2014

    Recall

    Recall Number
    Z-1609-2014
    Event Number
    68026
    Firm
    RM Temena GmbH Mittelhoefer Str. 1 D-34587 Felsberg Germany
    FEI Number
    3005379387
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 19, 2014
    Posted
    May 12, 2014
    Terminated
    September 19, 2016

    Description

    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance

    Reason

    Ultrasound needles may be defective and leak at the needle hub.

    Action

    Temena sent an Urgent Recall letter dated March 24, 2014, to the affected customers. The letter identified the product the problem and the action needed to be taken by the customer. IMPORTANT INSTRUCTIONS: 1. Ensure that the devices questions will not be applied to humans. 2. Opened packages shall not be used any more. 3. Please send us back the request of products (including opened packages) 4. Inform your distribution partners / further resellers about this recall to achieve a 100% recall of all unused products. 5.Please add a copy of our invoice / respectively of our delivery notes, to carry out a cost reimbursement or receive compensation delivery or a credit note. 6. Please use attached form to answer Temena SAS. Further questions please call: +33(0)1.30.86.05.30 We sincerely apologize for the inconvenience this may have caused by this product recall we thank you in advance for your support

    Distribution

    US Distribution including the states of MD and IL.

    Quantity

    7370 needles