BEUDAMED
    FDA Enforcement Class II Terminated

    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

    Recall: Z-1822-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1822-2020
    Event ID
    85260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 16, 2020
    Classification Date
    April 29, 2020
    Termination Date
    August 31, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

    Reason

    The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

    Code Info

    CORFLO* PEG Kit: Product Code: 30-6012 with lot# 0203214820, 0203251844 Product Code: 30-6016 with lot# 0002997221, 0020006332 Product Code: 30-6020 with lot# 0002994174, 0203251786 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-4016E1 with lot#: 0020008354, 0020008547, 0020008666 Product Code: 50-4020E1 with lot#: 0020008544 Product Code: 50-6012 with lot#: 0203214902, 0203245678 Product Code: 50-6012E1 with lot#: 0203251785, 0020003356 Product Code: 50-6012E2 with lot#: 0002997217, 0203239802, 2001368 Product Code: 50-6016E1 with lot#: 0002994170, 0203241062, 0203214905, 0203245676, 0203251843, 0020003029, 0203261078 Product Code: 50-6016E2 with lot#: 0203261079, 20012261, 0203239803, 0002994171, 20011367 Product Code: 50-6020 with lot#: 0203214903 Product Code: 50-6020E2 with lot#: 0203214901, 0203239804, 0203248168, 20011369 CORFLO* Safety PEG Kit with ENFit¿ Connector Product Code: 50-6316 with lot#: 0203241064 CORFLO* PEG Kit with ENFit¿ Connector Product Code: 50-6520 with lot#: 0203241063

    Distribution

    Worldwide and US Nationwide Distribution: AZ, CA, CT, FL, GA, IA, ID, IL, LA, MO, MN, MD, NY, NM, NV, NJ, OR, OK, OH, RI, TN, TX, WA, WI, ***Foreign: Distributed to Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Romania, United Arab Emirates, United Kingdom

    Quantity

    1766