BEUDAMED
    FDA Recall Terminated

    MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125

    Recall: Z-0566-2011 · Initiated November 15, 2010

    Recall

    Recall Number
    Z-0566-2011
    Event Number
    57315
    FEI Number
    1282497
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 15, 2010
    Posted
    December 9, 2010
    Terminated
    December 4, 2015
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125

    Reason

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

    Action

    COVIDEN 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 examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to [email protected] following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888

    Distribution

    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda

    Quantity

    1,356,480