BEUDAMED
    FDA Enforcement Class II Terminated

    SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.

    Recall: Z-0563-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0563-2019
    Event ID
    81361
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CIVCO Medical Instruments Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    November 2, 2018
    Classification Date
    December 7, 2018
    Termination Date
    November 20, 2020
    Address
    2301 Jones Blvd, N/A, Coralville, IA, 52241-3469, United States

    Description

    SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.

    Reason

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

    Code Info

    Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

    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

    1,375 boxes