Device recall: Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional…
Class II FDA enforcement event 72632. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.
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
CareFusion 303, Inc. started this device recall on 12 Nov 2015. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class II. FDA event 72632 has 1 product record. The first FDA enforcement report date is 30 Dec 2015. The record gives the status Terminated, with the termination date 23 Jan 2017.
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.
US Distribution.
Recalling firm
CareFusion 303, Inc., San Diego, CA.
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-0455-2016 | Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). | 157 units | Class II | Terminated | 30 Dec 2015 |
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 2015
- 1,153
- 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
- 99
Other events of the firm
Official channels
- FDA enforcement report Z-0455-2016The 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 72632. https://recallregister.com/fda/ii/72632/. 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:
US Distribution.
- What quantity of product is in FDA event 72632?
- The FDA record gives this quantity:
157 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.