Z-2935-2020Class II

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end...

Name: Z-2935-2020 BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end...
Creator: CareFusion 303, Inc.
Published: 2020-08-04
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2020-08-04 / Open, Classified / root cause: supplier

FDA source

CareFusion 303, Inc. began a recall of BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired... on 2020-08-04. FDA classified it as Class II and gives the reason as "Infusion pump component defect may result in interruption of patient monitoring". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2935-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-04
Posted: 2020-09-03
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.
Product code: PHC Infusion Safety Management Software
Reason for recall: Infusion pump component defect may result in interruption of patient monitoring
Root cause tag: supplier
FDA 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 : [email protected] 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: [email protected] for Product Complaints; (ii) 888-562-6018, [email protected] for Recall Related Questions and (iii) 888-812-3229, E-mail: [email protected] 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 in commerce: 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
Product codes and lots: Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2935-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2935-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-03

Product code PHC

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)