Recall Z-2356-2019

Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated June 20, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Norm-O-Temp model 111W

Codes / lots: Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161

Reason for recall

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

FDA-determined cause: Labeling False and Misleading

Action taken

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 FA2019-005@gentherm.com 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.

Details

Recall number
Z-2356-2019
Initiated
June 20, 2019
Terminated
June 9, 2020
Product code
DWJ – System, Thermal Regulating
Quantity
1063
Distribution
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…
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2355-2019 Class IINorm-O-Temp model 111ZThe manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause… 06/20/2019Terminated