CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report
Alaris EtCO2 recalled by CareFusion 303
CareFusion 303 is recalling Alaris EtCO2, distributed in 10 states. The recall was initiated on 1 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2443-2019
- FDA event ID
- 83296
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2019
- FDA classified
- 30 Aug 2019
- Reported
- 11 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2019 | Recall initiated by company | |
| 30 Aug 2019 | Classified by FDA | +60 days |
| 11 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Product as listed by the FDA
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Where it was distributed
US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
CaliforniaDistrict of ColumbiaIowaIllinoisKansasKentuckyMinnesotaNorth CarolinaSouth DakotaTexas
Questions about this recall
Is Alaris EtCO2 recalled?
Yes. CareFusion 303 recalled Alaris EtCO2 on 1 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2443-2019.
Why was it recalled?
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Which lots are affected?
Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 11634567; 15096411 11634567; 15091045 11634567; 15095827 11634567; 15090452 11634567; 15091016 11634567; 15091061 11634567; 15102989 11634567; 15096388 11634567; 15098536 11634567; 15098577 11634567; 15099809 11634567; 15099880 11634567; 15100031 11634567; 15101644 11634567; 15101802 11634567; 15102453 11634567; 15102532 11634567; 15091069 11634567; 15091118 11634567; 15102694 11634567; 15095732 11634567; 15095813 11634567; 15095837 11634567; 15095838 11634567; 15095745 11634567; 15096145 11634567; 15096189 11634567; 15096165 11634567; 15096179 11634567; 15096789 11634567; 15098732 11634567; 15101800 11634567; 15101856 11634567; 15101878 11634567; 15101902 11634567; 15101956 11634567; 15101984 11634567; 15102450 11634567; 15102465 11634567; 15102463 11634567; 15102547 11634567; 15102604 11634567; 15102565 11634567; 15102627 11634567; 15102639 11634567; 15102674 11634567; 15102901 11634567; 15102911 11634567; 15104015 11634567; 15104017 11634567; 15104041 11634567; 15102955 11634567; 15090987 8300ADXEN933; 15091002 8300ADXEN933; 15091053 8300ADXEN933; 15091228 8300ADXEN933; 15091270 8300ADXEN933; 15091272 8300ADXEN933; 15091274 8300ADXEN933; 15091297 8300ADXEN933; 15091311 8300ADXEN933; 15091350 8300ADXEN933; 15091321 8300ADXEN933; 15091347 8300ADXEN933; 15091352 8300ADXEN933; 15095743 8300ADXEN933; 15095794 8300ADXEN933; 15095805 8300ADXEN933 15101540 8300ADXEN933; 14976629 8300ADXEN933
Where was it sold?
US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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