BEUDAMED
    FDA Recall Terminated

    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Recall: Z-0445-2016 · Initiated November 5, 2015

    Recall

    Recall Number
    Z-0445-2016
    Event Number
    72583
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2015
    Posted
    December 17, 2015
    Terminated
    March 1, 2017
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    Reason

    CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

    Action

    An urgent recall letter dated 11/6/15 will be sent to all customers who purchased the Alaris Pump Module SmartSite Infusion Set because CareFusion has received reports of breakage of the spin collar on the male luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with questions related to recall 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, customer feedback@carefusion, 24 hrs/day, 7days/wk.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.

    Quantity

    1,445,180 units