Events

Recall of Device Recall Infinity Orange Enteral Feeding Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zevex International, 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
    50687
  • Event Risk Class
    Class 2
  • Event Number
    Z-2113-2009
  • Event Initiated Date
    2008-12-18
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76985
  • 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
    Enteral Infusion Pump - Product Code LZH
  • Reason
    Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
  • Action
    All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or sales@zevex.com. Distributors were to contact their customers and notify them of the letter.

Device

Device Recall Infinity Orange Enteral Feeding Pump
  • Model / Serial
    Serial numbers in range: 607129001 - 608275026
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
  • Product Description
    Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Manufacturer Address
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    USFDA