Events

Recall of ENTERALITE INFINITY SPIKE SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZEVEX 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
    68771
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The manufacturer has become aware of an increase in the number of complaints for enterlite infinity enteral pump delivery sets with enfit connector system and transitional stepped connectors (administration sets) that are used with the enteralite infinity enteral feeding pump. customers are reporting formula leaking between the purple enfit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.

Device

ENTERALITE INFINITY SPIKE SET
  • Model / Serial
    Model Catalog: INF0020-A (Lot serial: ); Model Catalog: INF1200-A (Lot serial: all); Model Catalog: INF0500-A (Lot serial: all)
  • Product Description
    Enteralite Infinity Spike Set
  • Manufacturer
    ZEVEX INC.

Manufacturer

ZEVEX INC.
  • Manufacturer Address
    SALT LAKE CITY
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    HC