FDA Medical Device Recalls (openFDA)
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 number
- Z-2935-2020
- Recalling firm
- CareFusion 303, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2020-08-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Infusion pump component defect may result in interruption of patient monitoring
- Root cause
- Vendor change control
- Action
- 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
- Quantity
- 680 units
- Distribution
- U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None
- Lot, serial or model codes
- Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569
- 510(k) numbers
- ["K133532"]
- PMA numbers
- not on file
- Product code
- PHC
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28