CareFusion 303, Inc. BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
Model: EtCO2 8300, Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569
Products Sold
Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569
CareFusion 303, Inc. is recalling BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring due to Infusion pump component defect may result in interruption of patient monitoring. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Infusion pump component defect may result in interruption of patient monitoring
Recommended Action
Per FDA guidance
On 8/4/2020,the firm sent an "Urgent Medical Device Recall" letter to customers with FedEX tracking. A customer response form is included with the letter that the customer is instructed to email or fax back to the firm. Returned response forms will be reconciled with the customer list. A response card will be included with the customer letter that is to be mailed, emailed or faxed back to the firm and will be reconciled with the customer list. Customers that do not respond to the initial mailing will be contacted up to a total of 3 times. The firm's Customer Response Form provided E-mail address as : BDRC21@bd.com and fax no.: 1-312-949-0437. The firm instructed their customers to contact the recall support center at 1-888-562-6018 to schedule remediation of recalled modules at no charge. The firm provided an additional phone numbers and E-mail addresses as: (i) 888-812-3266 and Email: customerfeedback@bd.com for Product Complaints; (ii) 888-562-6018, SupportCenter@bd.com for Recall Related Questions and (iii) 888-812-3229, E-mail: DL-US-INF-TechSupport@bd.com Additionally, any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDAs 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026