Events

Recall of Device Recall ThermaSure

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

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
    37018
  • Event Risk Class
    Class 2
  • Event Number
    Z-0712-2007
  • Event Initiated Date
    2006-12-21
  • Event Date Posted
    2007-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49770
  • 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
    Drying Cabinet - Product Code LDS
  • Reason
    Potential for user to receive an electrical shock.
  • Action
    Letter dated 12/20/2006 notifying customers of potential shock hazard under certain fault conditions and that a corrective action upgrade is being developed.

Device

Device Recall ThermaSure
  • Model / Serial
    Catalog #s 090033-02, 090033-04, 090034-02, 090034-04.  Serial Numbers: 330304, 330305, 330306, 330307, 330308, 330309, 330310, 330311, 330312, 330313, 330401, 330402, 330403, 340404, 330405, 340406, 330407, 330408, 330409, 330410, 330411, 340412, 330413, 330414, 330415, 330416, 340417, 340501, 330502, 330503, 330504, 330505, 340506, 330507, 330508, 330509, 330510, 330511, 330512, 330601, 330602, 330603, 330604, 330605, 330606, 330607, 330608, 330609, 330610, 330611.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    ThermaSure Medical Device Drying Cabinet, series 300
  • Manufacturer
    Cenorin

Manufacturer

Cenorin
  • Manufacturer Address
    Cenorin, 6324 S 199th Pl Ste 107, Kent WA 98032
  • Source
    USFDA