Events

Recall of Device Recall Integra 3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RESEARCH INSTRUMENTS LTD - SITE B.

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
    73581
  • Event Risk Class
    Class 2
  • Event Number
    Z-1584-2016
  • Event Initiated Date
    2016-03-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144524
  • 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
    Micromanipulators and microinjectors, assisted reproduction - Product Code MQJ
  • Reason
    The units have been fitted with a potentially faulty power supply cable.
  • Action
    Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions.

Device

Device Recall Integra 3
  • Model / Serial
    Serial numbers: 2-381
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
  • Product Description
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 || Product Usage: || The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
  • Manufacturer
    RESEARCH INSTRUMENTS LTD - SITE B

Manufacturer

RESEARCH INSTRUMENTS LTD - SITE B
  • Manufacturer Address
    RESEARCH INSTRUMENTS LTD - SITE B, Bickland Ind. Park, Falmouth United Kingdom
  • Source
    USFDA