Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during c
Summary
The FDA issued a Class II for Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 860 by Gentherm Medical, LLC. Reason: There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including N.
Details
Source
Device Recall
External ID
Z-2092-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Lot/Code Info: All units in service life Serial Numbers: 092-10011CE tot 212-11499CE
Quantity Affected: 1448 devices (1010 US; 438 OUS)
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-17
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Gentherm Medical, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gentherm Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gentherm Medical, LLC have FDA actions?
Gentherm Medical, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2092-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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