Z-0417-2020 Class II Terminated
FDA device recall Z-0417-2020 was initiated by Cincinnati Sub-Zero Products LLC, a Gentherm Company on July 2, 2019 and is designated Class II. 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 Automat… The recall status is terminated (terminated June 22, 2020). Affected quantity: 3932.
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
Reason for Recall
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.