Events

Recall of Flexiflo Quantum Enteral Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ross Products Division Abbott Laboratories.

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
    29856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0570-05
  • Event Initiated Date
    2004-08-18
  • Event Date Posted
    2005-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34668
  • 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
    Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
  • Action
    The firm contacted all consignees via telephone and letter on 08/18/2004.

Device

Flexiflo Quantum Enteral Pump
  • Model / Serial
    Serial #1061305 through 1061455 Serial #1061486 through 1061505 Serial #1061507 through 1061512 Serial #1061705 through 1061726
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed to the following states nationwide: MA, NJ, NY, PA, MD, VA, NC, SC, GA, FL, CA, TN, KY, OH, MI, SD, IL, KS, LA, AR, OK, TX, and CO.
  • Product Description
    Flexiflo Quantum Enteral Pump
  • Manufacturer
    Ross Products Division Abbott Laboratories

Manufacturer

Ross Products Division Abbott Laboratories
  • Manufacturer Address
    Ross Products Division Abbott Laboratories, 625 Cleveland Ave, Columbus OH 43215-1754
  • Source
    USFDA