BEUDAMED
    FDA Recall Terminated

    Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.

    Recall: Z-0218-2008 · Initiated August 30, 2007

    Recall

    Recall Number
    Z-0218-2008
    Event Number
    44826
    Firm
    Cardinal Health 303 Inc DBA Alaris Products
    FEI Number
    3003879246
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    August 30, 2007
    Posted
    November 8, 2007
    Terminated
    March 28, 2012
    Address
    10221 Wateridge Cir, San Diego, CA, 92121-2733

    Description

    Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.

    Reason

    Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)

    Action

    Recall notification was made via a Safety Alert Notification Letter dated August 30, 2007. Recall will be conducted through consignees (distributors) in the affected countries, as well as, direct customers for the Texium closed male luer. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management, and Director of Pharmacy at each facility. Distributors were sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their sub-account customers. The domestic letters (direct customers and distributors) were mailed on August 30, 2007 to all of the affected accounts. The international notifications will be coordinated out of the offices located in the affected countries. The appropriate international regulatory authorities will be notified of this issue, which will work with the country managers at each location.

    Distribution

    Worldwide: USA including states of Arkansas, California, Colorado, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New England, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin. and countries of Australia, Canada, Japan and Switzerland

    Quantity

    76, 300 units