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Terminated

Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

FDA Recall Z-0418-2020 · Posted None

Recalling FirmCincinnati Sub-Zero Products LLC, a Gentherm Company
Recall StatusTerminated
Product CodeDWJ
Date Initiated2019-07-02
Date Terminated2020-06-22
Product Quantity3726

Reason for Recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Firm Action

Gentherm issued URGENT Medical Device Correction, Blanketrol II letters were mailed by USPS starting July 25th and Blanketrol III letters were mailed by USPS starting July 30th. Letters stated problem, health risk and action to take: INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at (513)326-5320. 2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice. 3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to FA2019-004/[email protected], or mail to: Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241. Questions, call Gentherm Medical Technical Support at 1-888-437-5608 or Stephanie Vocke @ (513)719-3262

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110104BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEMCincinnati Sub-Zero Products, Inc. · 2011-02-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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