Events

Recall of Device Recall Blanketrol III Data Export Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products 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
    66632
  • Event Risk Class
    Class 2
  • Event Number
    Z-0443-2014
  • Event Initiated Date
    2013-05-15
  • Event Date Posted
    2013-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122858
  • 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
    System, thermal regulating - Product Code DWJ
  • Reason
    During a customer inquiry regarding a beta version of the bill data export software, model usb-127, it was discovered that the wrong software version was released to a customer.
  • Action
    Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They instructed their customers to to do the following: 1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ. 2) After the Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to BIIIExportSoftware@cszinc.com, or mail to: Cincinnati Sub-Zero 12011 Mosteller Road Cincinnati, OH 45241 U.S.A. For further questions please call 1-(800) 989-7373 or (513) 772-8810.

Device

Device Recall Blanketrol III Data Export Software
  • Model / Serial
    Product/Part #86127, Catalog #USB-127, Lot #00554
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
  • Product Description
    Blanketrol III Data Export Software Version 1.10 || The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA