Recall of Device Recall CO2 Incubators (General Purpose Incubator),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thermo Fisher Scientific (Asheville) LLC.

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
    64418
  • Event Risk Class
    Class 2
  • Event Number
    Z-1079-2013
  • Event Initiated Date
    2012-11-29
  • Event Date Posted
    2013-04-10
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-04-14
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Bath, incubators/water, all - Product Code JTQ
  • Reason
    Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
  • Action
    Thermo Fisher sent an Urgent Field Correction Notice letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate all affected products and determine if it is within the recall. If so, they are to return the Acknowledgement Form in order to get replacement hinges and instructions. Upon receipt of the new hinges they are to replace them according to the instructions.

Device

  • Model / Serial
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.
  • Product Description
    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. || Product Usage: || Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Thermo Fisher Scientific (Asheville) LLC, 401 Mill Creek Rd, Marietta OH 45750-4304
  • Manufacturer Parent Company (2017)
  • Source
    USFDA