BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2178-2017 · Initiated April 27, 2017

    Recall

    Recall Number
    Z-2178-2017
    Event Number
    77129
    Firm
    AbbVie Inc.
    FEI Number
    3009751352
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 27, 2017
    Terminated
    July 9, 2019
    Address
    1 N Waukegan Rd, North Chicago, IL, 60064-1802

    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.

    Action

    On April 27, 2017, firm sent letter (and response form) to customers, instructing them to inspect their inventory for affected lots and arrange a replacement kit to be delivered by AbbVie if a kit with missing components is discovered. Distributors were asked to notify their customers. Any returned affected product will be destroyed.

    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