Events

Recall of Device Recall KimberlyClark MIC Safety PEG Kit Pull Type

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kimberly-Clark Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63001
  • Event Risk Class
    Class 2
  • Event Number
    Z-2415-2012
  • Event Initiated Date
    2010-06-22
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112227
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • 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.
  • Action
    Kimberly-Clark Health Care sent an Urgent Voluntary Medical Device Withdrawal letter dated June 22, 2010, to all affected customers. The letter included a Product Withdrawal Response Sheet which was to be returned to Kimberly-Clark. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and destroy all affected products and complete the attached Product Withdrawal Response Sheet and Fax the form to 920-225-4182. For questions customers should call 770-587-7362. For questions regarding this recall call 770-587-8393.

Device

Device Recall KimberlyClark MIC Safety PEG Kit Pull Type
  • Model / Serial
    Lots AW916102A
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Kimberly-Clark MIC Safety 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.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA