Class 2 Device Recall CoolBlue Model 2501 HyperHypohermia System (Model Innercool)

• Date Initiated by Firm: July 02, 2019
• Create Date: November 18, 2019
• Recall Status: Terminated on June 22, 2020
• Recall Number: Z-0419-2020
• Recall Event ID: 83464
• 510(K)Number: K101589
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: CoolBlue Hyper-Hypothermia System- body hypothermia system; Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
• Code Information: Serial Numbers: 073-CB-00001 through 162-CB-00294
• Recalling Firm/ Manufacturer: Cincinnati Sub-Zero Products LLC, a Gentherm Company; 12011 Mosteller Rd; Cincinnati OH 45241-1528
• For Additional Information Contact: SAME; 513-772-8810
• Manufacturer 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
• FDA Determined Cause: Labeling False and Misleading
• 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 FA2019-004/010@gentherm.com, 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
• Quantity in Commerce: 5291
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ and Original Applicant = CINCINNATI SUB-ZERO PRODUCTS, INC.