Events

Recall of 115V Blanketroll III Model 233 and 115V CoolBlue Model 2501

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
    57004
  • Event Risk Class
    Class 2
  • Event Number
    Z-1817-2011
  • Event Initiated Date
    2010-10-18
  • Event Date Posted
    2011-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97410
  • 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
    Thermal Regulating System - Product Code DWJ
  • Reason
    The firm initiated this recall due to changes that have been made to the blanketrol iii model 233 device's operation and operation/technical service manuals, in order to stay in compliance with labeling regulations.
  • Action
    On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.

Device

115V Blanketroll III Model 233 and 115V CoolBlue Model 2501
  • Model / Serial
    Model 233, Serial Numbers 061-3-00001 through 101-3-01389 and Model 25-01, Serial Numbers 073-CB-00001 through 094-CB-00138.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.
  • Product Description
    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. || Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
  • 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
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA