BEUDAMED
    FDA Recall Terminated

    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

    Recall: Z-1703-2016 · Initiated April 26, 2016

    Recall

    Recall Number
    Z-1703-2016
    Event Number
    74171
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 26, 2016
    Posted
    May 20, 2016
    Terminated
    March 10, 2017
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

    Reason

    Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

    Action

    The firm, B. Braun Medical Inc., sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 4/26/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate their current inventory for the affected lots; fill out the Product Removal Acknowledgement form and record the total number of units found, and return the form to B. Braun Medical Inc. Quality Assurance department by faxing the form to 610-849-1197 or email to PA_Quality [email protected] within two weeks of receipt. A BBMI Customer Support Representative will contact the customer to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.

    Distribution

    Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

    Quantity

    5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]