Recall Z-2443-2019— CareFusion 303, Inc.

Name: FDA recall Z-2443-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-01

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2019-07-01, terminated 2020-09-09. It names one FDA 510(k) clearance: K031741. Product: Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933. Reason: Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2.

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-01
Terminated: 2020-09-09
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300Alaris Medical Systems, Inc.·cleared 2004-02-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.