Hemotherm CE Dual Reservoir Cooler/Heater Recalled for Overheating Risk
Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used during cardiopulmonary bypass where overheating and device shutdown pose a risk of harm to the patient, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 396 units of the Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE. The device is used to control the temperature of water flowing through a blood oxygenator or heat exchanger during cardiopulmonary bypass procedures, or to provide warming through conductive heat transfer with a hyper/hypothermia blanket.
The recall was initiated because evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched. This stretching caused the clips to no longer be mechanically tight with the fuse, creating a hot spot that led to discoloration on the board due to overheating and subsequent shutdown of the device.
The affected products were distributed worldwide, including nationwide in the United States 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, as well as in Columbia and Taiwan. The affected serial numbers range from 151-10283CE through 171-10721CE. Users should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- 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 Blood Oxygenator / Heat Exchanger that is used to cool or…
- Affected units
- 396
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers 151-10283CE through 171-10721CE
Distribution
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