BEUDAMED
    FDA Recall Terminated

    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

    Recall: Z-1179-2016 · Initiated February 15, 2016

    Recall

    Recall Number
    Z-1179-2016
    Event Number
    73238
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 15, 2016
    Terminated
    October 24, 2016
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

    Reason

    CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

    Action

    A customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact Customer Advocacy at (888)812-3266, [email protected], 24 hrs/day, 7 days/wk. Customers are instructed to complete and return the enclosed mandatory customer response card to acknowledge the receipt of the customer communication.

    Distribution

    Michigan

    Quantity

    5,760 units