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U.S. Department of Health and Human Services

Class 2 Device Recall Hemotherm CE Dual Reservoir Cooler/Heater

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 Class 2 Device Recall Hemotherm CE Dual Reservoir Cooler/Heatersee related information
Date Initiated by FirmDecember 19, 2018
Create DateFebruary 13, 2019
Recall Status1 Terminated 3 on April 24, 2020
Recall NumberZ-0825-2019
Recall Event ID 81961
510(K)NumberK122813 
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
ProductHemotherm 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 warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.
Code Information Serial numbers 151-10283CE through 171-10721CE
FEI Number 1516825
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products LLC, a Gentherm Company
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information ContactBeatrice G. Washington
513-772-8810
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionInitial notification letters were sent to customers on 12/19/18 to inform them of the upcoming field action. An additional letter sent to customers on 1/18/19 providing instructions on the correction. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce396
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DWC
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