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U.S. Department of Health and Human Services

Class 2 Device Recall Hemotherm 400CE

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  Class 2 Device Recall Hemotherm 400CE see related information
Date Initiated by Firm June 17, 2021
Create Date July 19, 2021
Recall Status1 Terminated 3 on March 01, 2023
Recall Number Z-2092-2021
Recall Event ID 88187
510(K)Number K122813  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Code Information All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
Recalling Firm/
Manufacturer		 Gentherm Medical, LLC
12011 Mosteller Rd Fl 3
Blue Ash OH 45241-1528
For Additional Information Contact Gentherm Medical Technical Support
888-437-5608
Manufacturer Reason
for Recall		 There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
FDA Determined
Cause 2		 Process control
Action On 6/17/2021, Gentherm issued Urgent Medical Device Recall notices and response forms to customers via courier service. Instructions to Customers: 1) Immediately examine your inventory, access updated manuals and ensure obsolete manuals are removed from service. 2) Updated manuals may be accessed via www.gentherm.com or physicial copies may be requested from Gentherm Medical, LLC at 1-888-437-5608. 3) Ensure that all users are informed of the contents of this letter. 4) If you have further distributed this product, please provide those accounts with a copy of this notice. 5) Complete and return the customer response form via email to FA2021-004@gentherm.com.
Quantity in Commerce 1448 devices (1010 US; 438 OUS)
Distribution Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWC and Original Applicant = CINCINNATI SUB-ZERO PRODUCTS, INC.
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