BEUDAMED
    FDA Enforcement Class II Terminated

    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

    Recall: Z-2178-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2178-2017
    Event ID
    77129
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AbbVie Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    April 27, 2017
    Classification Date
    May 31, 2017
    Termination Date
    July 9, 2019
    Address
    1 N Waukegan Rd, North Chicago, IL, 60064-1802, United States

    Description

    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

    Reason

    PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.

    Code Info

    Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215

    Distribution

    Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey

    Quantity

    3,331 kits