BEUDAMED
    FDA Recall Terminated

    Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013

    Recall: Z-1078-2007 · Initiated June 5, 2007

    Recall

    Recall Number
    Z-1078-2007
    Event Number
    38215
    Firm
    Cardinal Health 303 Inc DBA Alaris Products
    FEI Number
    3003879246
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2007
    Posted
    August 3, 2007
    Terminated
    February 10, 2012
    Address
    10221 Wateridge Cir, San Diego, CA, 92121-2733

    Description

    Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013

    Reason

    The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.

    Action

    Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.

    Distribution

    Nationwide.

    Quantity

    4,248 sets (59 boxes)