BEUDAMED
    FDA Recall Terminated

    Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227

    Recall: Z-0446-2016 · Initiated November 13, 2015

    Recall

    Recall Number
    Z-0446-2016
    Event Number
    72690
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DXO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 13, 2015
    Terminated
    July 15, 2016
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227

    Reason

    Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.

    Action

    An urgent product notification letter dated 11/13/15 was to customers to inform them that during an internal documentation review, the requirement of an additional FDA submission to support commercialization (clearance) of the devices was discovered. Customers are informed that the Edwards Lifesciences Intravascular (IV) Administration sets are temporarily unavailable for sale. Customers are informed that there is no increased risk to the patients' health or safety by using products in their current inventory and there is no impact to the IV sets included in pressure monitoring kits (with TruWave pressure transducer or VAMP system). Customers are informed that if they are in need of a substitute IV set, then to call customer service at (800) 424-3278. Customers instructed to respond to the customer response form by faxing it to (800) 422-9329.

    Distribution

    US

    Quantity

    147,350 units