Home / Recalls / Cincinnati Sub-Zero Products LLC, a Gentherm Company / Z-2291-2019

Z-2291-2019 Class III Terminated

Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company — Cincinnati, OH

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

Other recalls by Cincinnati Sub-Zero Products LLC, a Gentherm Company

  • Z-0419-2020 Class II — CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - P (July 2, 2019)
  • Z-0417-2020 Class II — Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature man (July 2, 2019)
  • Z-0418-2020 Class II — Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: T (July 2, 2019)
  • Z-2355-2019 Class II — Norm-O-Temp model 111Z (June 20, 2019)
  • Z-2356-2019 Class II — Norm-O-Temp model 111W (June 20, 2019)
  • Z-0825-2019 Class II — Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: Th (December 19, 2018)
  • Z-0063-2019 Class II — Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservo (September 4, 2018)