BEUDAMED
    FDA Recall Terminated

    MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014

    Recall: Z-1569-2011 · Initiated November 15, 2010

    Recall

    Recall Number
    Z-1569-2011
    Event Number
    57314
    FEI Number
    1282497
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 15, 2010
    Posted
    March 7, 2011
    Terminated
    December 4, 2015
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014

    Reason

    The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.

    Action

    Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the product, and return it to the firm. Distributors were instructed to notify their customers. All customers were required to respond to the notice regardless of their remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customers Service questions regarding this recall call 1-800-962-9888 option 1.

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KS, KY, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, MV, MY, OH, OK, PA, SC, SD, TN, TX, WA, and WI and the country of Canada

    Quantity

    18,100