Z-2291-2019 Class III Terminated
FDA device recall Z-2291-2019 was initiated by Cincinnati Sub-Zero Products LLC, a Gentherm Company on July 19, 2019 and is designated Class III. Reason for recall: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage The recall status is terminated (terminated May 13, 2020). Affected quantity: 2079 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2079 units
Product Description
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Reason for Recall
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Distribution Pattern
Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Code Information
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165