BEUDAMED
    FDA Enforcement Class II Terminated

    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.

    Recall: Z-1003-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1003-2017
    Event ID
    75810
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    J&J Solutions, Inc. DBA Corvida Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 18, 2017
    Initiation Date
    November 22, 2016
    Classification Date
    January 11, 2017
    Termination Date
    November 9, 2018
    Address
    2261 Crosspark Rd Ste 127, Coralville, IA, 52241-4716, United States

    Description

    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.

    Reason

    Product malfunction: Needle does not retract.

    Code Info

    Lot 0610525, 2017-10-18

    Distribution

    US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.

    Quantity

    5520 units