CareFusion 303, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2443-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

Product Classification:

Class II

Date Initiated: July 1, 2019

Date Posted: September 11, 2019

Recall Number: Z-2443-2019

Event ID: 83296

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

Status: Terminated

Product Quantity: 76 EtCO2 units

Code Information:

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

Distribution Pattern:

US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia

Voluntary or Mandated:

Voluntary: Firm initiated