BEUDAMED
    FDA Recall Terminated

    Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin

    Recall: Z-1694-2012 · Initiated May 21, 2012

    Recall

    Recall Number
    Z-1694-2012
    Event Number
    61908
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 21, 2012
    Posted
    May 31, 2012
    Terminated
    June 10, 2013
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113

    Description

    Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin

    Reason

    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick

    Action

    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to [email protected]. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:[email protected]

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.

    Quantity

    952,000 syringes