Events

Recall of Infinity Enteral Feeding infusion pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MOOG Medical Devices Group.

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
    63485
  • Event Risk Class
    Class 2
  • Event Number
    Z-0764-2013
  • Event Initiated Date
    2012-10-12
  • Event Date Posted
    2013-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113975
  • 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
    Pump, infusion, enteral - Product Code LZH
  • Reason
    The firm is adding an addendum to the operator's manual for infinity enteralite ambulatory feeding pumps pertaining to the infinite dose mode and the inability of the pump to detect air in line.
  • Action
    An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: himesstark@moog.com.

Device

Infinity Enteral Feeding infusion pump
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
  • Product Description
    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual || Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Manufacturer Address
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA