Recall Z-2355-2019 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Norm-O-Temp model 111Z
| Date | Jun 20, 2019 |
| Status | Terminated |
| Reason | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. |
| Root cause | Labeling False and Misleading |
| 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 FA2019-005@gentherm.com or mail to : Gentherm Medica |
| Quantity | 674 |
| 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 Ecu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS Cincinnati Sub-Zero Products, Inc., Feb 17, 2012 |