BEUDAMED
    FDA Recall Terminated

    CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.

    Recall: Z-0562-2019 · Initiated November 2, 2018

    Recall

    Recall Number
    Z-0562-2019
    Event Number
    81361
    Firm
    CIVCO Medical Instruments Co., Inc.
    FEI Number
    3012763756
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2018
    Terminated
    November 20, 2020
    Address
    2301 Jones Blvd, Coralville, IA, 52241-3469

    Description

    CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.

    Reason

    The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

    Action

    The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory.

    Distribution

    Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

    Quantity

    738 boxes