Z-0417-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- July 2, 2019
- Termination Date
- June 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3932
Product Description
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
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
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.
Code Information
Serial Numbers: 071-3-00123 through193-3-09498