BEUDAMED
    FDA Enforcement Class II Terminated

    Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

    Recall: Z-2416-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2416-2012
    Event ID
    63001
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 26, 2012
    Initiation Date
    June 22, 2010
    Classification Date
    September 20, 2012
    Termination Date
    February 7, 2013
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076, United States

    Description

    Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

    Reason

    The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

    Code Info

    Lots AW916002A, AW916102D

    Distribution

    Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.

    Quantity

    766 units