Norm-O-Temp model 111Z
FDA Recall Z-2355-2019 · Posted None
Recalling FirmCincinnati Sub-Zero Products LLC, a Gentherm Company
Recall StatusTerminated
Product CodeDWJ
Date Initiated2019-06-20
Date Terminated2020-06-09
Product Quantity674
Reason for Recall
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Firm Action
1. Access updated manuals and ensure that obsolete manuals are removed from services. updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-5608
2. Inform the content of the notification to all users and if you have further distributed this product, please provide those account with a copy of this notice.
3. Please complete and return the enclosed response form as soon as receipt of this notification and to inform Gentherm Medical, LLC and return the form by e-mail to [email protected] or mail to : Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241.
If you have any questions, call Gentherm Medical Technical Support at 1-888-437-5608.
Root Cause
Labeling False and Misleading
Distribution Pattern
Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.