BEUDAMED
    FDA Recall Terminated

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    Recall: Z-2888-2018 · Initiated February 23, 2018

    Recall

    Recall Number
    Z-2888-2018
    Event Number
    80704
    Firm
    Civco Medical Instruments Co. Inc.
    FEI Number
    1937223
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 23, 2018
    Terminated
    October 6, 2020
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    Reason

    A cover failed leak testing during validation testing of new needle guides from a replacement tool.

    Action

    Telephone Script to be read: CIVCO is calling to notify our customers regarding a recall action being initiated. CIVCO has recently discovered a dimensional issue in our Infiniti bracket which may allow the needle guide to a puncture a cover. You are being notified, as your facility has been identified as having received product from one of the affected manufacturing lots. Advise on Action to be taken by Customer or Distributor: To return Infiniti needle guide, contact your Account Representative at 800-445-6741 or 319-248-6757. Alternately you may also use email at [email protected] to schedule the return of your device. Additional information to obtain: Verification of Email contact to send notification letter and response letter.

    Distribution

    Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada

    Quantity

    177 boxes