BEUDAMED
    FDA Recall Terminated

    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes.

    Recall: Z-2798-2011 · Initiated June 8, 2010

    Recall

    Recall Number
    Z-2798-2011
    Event Number
    58863
    Firm
    Terumo Medical Corporation
    FEI Number
    1118880
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 8, 2010
    Posted
    July 13, 2011
    Terminated
    July 14, 2011
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322

    Description

    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes.

    Reason

    Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025

    Action

    The firm, Terumo Medical Corporation sent an "URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a "Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

    Distribution

    Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA

    Quantity

    453,000 needles