FDA recall Z-2443-2019

Product

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

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-01

Report date

2019-09-11

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2443-2019