Events

Recall of AbbVie PEG, PEG Kit 15FR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AbbVie Inc..

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
    77129
  • Event Risk Class
    Class 2
  • Event Number
    Z-2177-2017
  • Event Initiated Date
    2017-04-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155421
  • 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
    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.

Device

AbbVie PEG, PEG Kit 15FR
  • Model / Serial
    Material/List number: 629100116 Lots: 32025235, 32184275, 32354106, 32365305, 32435265
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
  • Manufacturer
    AbbVie Inc.

Manufacturer

AbbVie Inc.
  • Manufacturer Address
    AbbVie Inc., 1 N Waukegan Rd, North Chicago IL 60064-1802
  • Manufacturer Parent Company (2017)
    Abbvie Inc.
  • Source
    USFDA