Events

Recall of Device Recall ThermaSure(TM), a CENORIN(TM) product, 130 Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cenorin, 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
    77637
  • Event Risk Class
    Class 2
  • Event Number
    Z-3032-2017
  • Event Initiated Date
    2017-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157001
  • 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
    Unit, drying - Product Code JRJ
  • Reason
    Dryer unit not heating. manufacturing issue causes the terminal block to overheat, char and/or burn.
  • Action
    Cenorin initially contacted all domestic customers at the facility and distributor level via phone on June 7, 2017, which was followed by an Urgent Medical Device Recall letter dated July 20, 2017, to all affected customers. Cenorin sent initial notification to international distributors via email. Customers were asked to immediately examine their inventory for the affected product. If the product exhibits any symptoms of failure, immediately cease using it and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042, ext 224.

Device

Device Recall ThermaSure(TM), a CENORIN(TM) product, 130 Series
  • Model / Serial
    (a) Serial Numbers: 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, 351624  (b) Serial numbers: 361505, 361511, 361515, 361601, 361603, 361607, 361608,  361612
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
  • Product Description
    ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 || Forced air dryer for medical devices
  • Manufacturer
    Cenorin, LLC

Manufacturer

Cenorin, LLC
  • Manufacturer Address
    Cenorin, LLC, 6324 S 199th Pl, Suite 107, Kent WA 98032
  • Manufacturer Parent Company (2017)
    Cenorin L.L.C.
  • Source
    USFDA