Reported Dec 30, 2015 · Terminated
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional…
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 EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
- Lot codes and dates
157 of 157 codes
9905776990579212331254123504101235241012364342123643431236490112369088124013281240258312479923124812391259372112623833126239571266825312679872126972421269854212736367128057821280775712868325128700211291651812918611129190791292115713034011130343751303812413050300130506481305103413061112130728291307541213077962130888231310602913106030131061381310614013122164131224011312240213122936131367861314156513142603131436601314380913143889131672551316967213173261131772101317824813178389
- Amount recalled
- 157 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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