Reported Sep 11, 2019 · Terminated
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
CareFusion 303, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
Alaris EtCO2Model 8300
- UDI10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- Lot codes and dates
74 of 74 codes
Serial #/Model # 15098573 1163456715111502 1163456715096360 1163456715098699 1163456715099681 1163456715096411 1163456715091045 1163456715095827 1163456715090452 1163456715091016 1163456715091061 1163456715102989 1163456715096388 1163456715098536 1163456715098577 1163456715099809 1163456715099880 1163456715100031 1163456715101644 1163456715101802 1163456715102453 1163456715102532 1163456715091069 1163456715091118 1163456715102694 1163456715095732 1163456715095813 1163456715095837 1163456715095838 1163456715095745 1163456715096145 1163456715096189 1163456715096165 1163456715096179 1163456715096789 1163456715098732 1163456715101800 1163456715101856 1163456715101878 1163456715101902 1163456715101956 1163456715101984 1163456715102450 1163456715102465 1163456715102463 1163456715102547 1163456715102604 1163456715102565 1163456715102627 1163456715102639 1163456715102674 1163456715102901 1163456715102911 1163456715104015 1163456715104017 1163456715104041 1163456715102955 1163456715090987 8300ADXEN93315091002 8300ADXEN93315091053 8300ADXEN933
- Amount recalled
- 76 EtCO2 units
Where it was sold
Why it was recalled
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
This product could cause temporary or reversible health problems — stop using it.
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