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

Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2

On July 3, 2019, a "Medical Device Product Notification" letter was sent via FED Ex 2-day delivery with signature required. The letter informs consignees of the following: 1. Customers with the affected serial numbers should call the BD Support Center at 888-562-6018 to schedule service of the devices at the BD Service Depot. 2. BD will contact all affected facilities within 60 days to initiate the return process for the affected EtCO2 modules. BD will recalibrate the EtCO2 modules using a 5% CO2 gas concentration and send the devices back to the customer. 3. The US Food and Drug Administration has been notified of this action. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by: " Web: MedWatch website at www.fda.gov/medwatch " Phone: 1-800-FDA-1088 " Fax: 1-800-FDA-0178, or by "Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 4. Please promptly complete and return the enclosed Customer Response Card to acknowledge receipt of this notification. 5. If you have any questions regarding the products, please contact BD Support Center at 888-562-6018.