Cincinnati, OH, United States
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls
5 recalls recorded since 2018, most recently on 19 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 19 July 2019
- Terminated
- 13 May 2020
- Reason
- Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
- Distribution
- Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2291-2019
- MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Terminated Class II Medical devices
- Recall started
- 2 July 2019
- Terminated
- 22 June 2020
- Reason
- Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
- Distribution
- Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0419-2020, Z-0417-2020, Z-0418-2020
- CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
- Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
- Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Terminated Class II Medical devices
- Recall started
- 20 June 2019
- Terminated
- 9 June 2020
- Reason
- The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
- 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 Thaila
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2355-2019, Z-2356-2019
- Norm-O-Temp model 111Z
- Norm-O-Temp model 111W
Terminated Class II Medical devices
- Recall started
- 19 December 2018
- Terminated
- 24 April 2020
- Reason
- Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0825-2019
- Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Bl
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 23 May 2019
- Reason
- Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0063-2019
- Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.