Device recall: Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during…
Class II FDA enforcement event 88187. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
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
Gentherm Medical, LLC started this device recall on 17 Jun 2021. The firm address in the FDA record is in Blue Ash, OH. FDA put the recall in Class II. FDA event 88187 has 1 product record. The first FDA enforcement report date is 28 Jul 2021. The record gives the status Terminated, with the termination date 1 Mar 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan,…
Recalling firm
Gentherm Medical, LLC, Blue Ash, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2092-2021 | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures | 1448 devices (1010 US; 438 OUS) | Class II | Terminated | 28 Jul 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Jul 2026 | Blanketrol II Model 222S; Thermal regulating system. | Device | Class II | 3 |
| 22 Nov 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2092-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 88187. https://recallregister.com/fda/ii/88187/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan,…
- What quantity of product is in FDA event 88187?
- The FDA record gives this quantity:
1448 devices (1010 US; 438 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.