Recall Z-2291-2019
Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated July 19, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Codes / lots: Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
Reason for recall
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
FDA-determined cause: Under Investigation by firm
Action taken
Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.
Details
- Recall number
- Z-2291-2019
- Initiated
- July 19, 2019
- Terminated
- May 13, 2020
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 2079 units
- Distribution
- Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH