Events

Recall of ambIT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorenson Medical, 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
    36505
  • Event Risk Class
    Class 2
  • Event Number
    Z-0186-2007
  • Event Initiated Date
    2006-10-10
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48772
  • 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
    Ambulatory infusion pump cassette. - Product Code FRN
  • Reason
    Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
  • Action
    Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .

Device

ambIT
  • Model / Serial
    REF 220140, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
  • Product Description
    ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.
  • Manufacturer
    Sorenson Medical, Inc.

Manufacturer

Sorenson Medical, Inc.
  • Manufacturer Address
    Sorenson Medical, Inc., 1375 W 8040 S, West Jordan UT 84088-8320
  • Source
    USFDA