Events

Recall of Device Recall Infinity 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
    63660
  • Event Risk Class
    Class 2
  • Event Number
    Z-0294-2013
  • Event Initiated Date
    2012-11-08
  • Event Date Posted
    2012-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114426
  • 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
    Moog medical devices group is conducting a voluntary for a limited set of serial numbers of the enteralite infinity and infinity orange small volume enteral feeding pumps because certain diodes on the pcb assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
  • Action
    MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.

Device

Device Recall Infinity Pump
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
  • Product Description
    EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. || The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories 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