Recall Z-0418-2020
Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated July 2, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)
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 taken
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
Details
- Recall number
- Z-0418-2020
- Initiated
- July 2, 2019
- Terminated
- June 22, 2020
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 3726
- 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…
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0417-2020 Class II | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management…Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage.… | 07/02/2019Terminated |
| Z-0419-2020 Class II | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product…Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage.… | 07/02/2019Terminated |