Events

Recall of Device Recall Compat

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

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
    25470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0608-03
  • Event Initiated Date
    2003-01-27
  • Event Date Posted
    2003-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25976
  • 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
    Some of the sets may leak or disconnect near the pump adapter during use. the patient could ingest air and vomit causing a safety concern.
  • Action
    The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.

Device

Device Recall Compat
  • Model / Serial
    Item number 19931200, lots 3152A and 3182A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States and to Canada
  • Product Description
    Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
  • Manufacturer
    Novartis Nutrition Corp

Manufacturer

Novartis Nutrition Corp
  • Manufacturer Address
    Novartis Nutrition Corp, 1541 Park Place Blvd, St Louis Park MN 55416
  • Source
    USFDA