BEUDAMED
    FDA Recall Completed

    Enteral Infusion Pump

    Recall: Z-1347-2021 · Initiated January 19, 2021

    Recall

    Recall Number
    Z-1347-2021
    Event Number
    87281
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    LZH
    Status
    Completed
    Root Cause
    Process control
    Initiated
    January 19, 2021
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Enteral Infusion Pump

    Reason

    The potential for air appearing in the enteral feed pumping set tubing during set-up.

    Action

    On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes

    Distribution

    Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey

    Quantity

    146,944,334 units