Device recall: 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or…
Class II FDA enforcement event 68356. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
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 Inc started this device recall on 8 Jan 2014. The firm address in the FDA record is in Cincinnati, OH. FDA put the recall in Class II. FDA event 68356 has 1 product record. The first FDA enforcement report date is 11 Jun 2014. The record gives the status Terminated, with the termination date 6 Jun 2014.
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.
The product was distributed to one customer in MI, and internationally (Taiwan)
Recalling firm
Cincinnati Sub-Zero Products Inc, 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-1679-2014 | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165. | 7 units | Class II | Terminated | 11 Jun 2014 |
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 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Mar 2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Device | Class II | 1 |
| 7 Nov 2016 | The Hemotherm 400CE 115v, containing power board p/n 39945 | Device | Class II | 1 |
| 7 Jan 2015 | Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local c | Device | Class II | 1 |
| 3 Sep 2013 | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-H | Device | Class II | 1 |
| 15 May 2013 | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the elec | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1679-2014The 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 68356. https://recallregister.com/fda/ii/68356/. 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:
The product was distributed to one customer in MI, and internationally (Taiwan)
- What quantity of product is in FDA event 68356?
- The FDA record gives this quantity:
7 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.