BEUDAMED
    FDA Recall Terminated

    Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Tyco Healthcare, Mansfield, MA 02048

    Recall: Z-1594-2008 · Initiated March 28, 2008

    Recall

    Recall Number
    Z-1594-2008
    Event Number
    47436
    FEI Number
    1282497
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 28, 2008
    Posted
    May 9, 2008
    Terminated
    June 25, 2012
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Tyco Healthcare, Mansfield, MA 02048

    Reason

    Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant.

    Action

    Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .

    Distribution

    Nationwide Distribution

    Quantity

    115,140 units