Alaris EtCO2 recall
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Why was Alaris EtCO2 recalled?
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 76 EtCO2 units
- Distribution
- US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)