Device recall: Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir…
Class II FDA enforcement event 81961. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
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
Cincinnati Sub-Zero Products LLC, a Gentherm Company started this device recall on 19 Dec 2018. The firm address in the FDA record is in Cincinnati, OH. FDA put the recall in Class II. FDA event 81961 has 1 product record. The first FDA enforcement report date is 20 Feb 2019. The record gives the status Terminated, with the termination date 24 Apr 2020.
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 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…
Recalling firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, 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-0825-2019 | 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 warm blood during cardiopulmonary bypass… | 396 | Class II | Terminated | 20 Feb 2019 |
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 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Jul 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conduct | Device | Class III | 1 |
| 2 Jul 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The s | Device | Class II | 3 |
| 20 Jun 2019 | Norm-O-Temp model 111Z | Device | Class II | 2 |
| 4 Sep 2018 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or | Device | Class II | 1 |
Cincinnati Sub-Zero Products LLC, a Gentherm Company: all 5 events
Official channels
- FDA enforcement report Z-0825-2019The 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 81961. https://recallregister.com/fda/ii/81961/. 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 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…
- What quantity of product is in FDA event 81961?
- The FDA record gives this quantity:
396
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.