Recall Z-0418-2020 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products LLC, a Gentherm Company
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.
| Date | Jul 2, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root 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, plea |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM Cincinnati Sub-Zero Products, Inc., Feb 4, 2011 |