CareFusion 303, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2935-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 4, 2020

Date Posted: September 9, 2020

Recall Number: Z-2935-2020

Event ID: 85997

Reason for Recall:

Infusion pump component defect may result in interruption of patient monitoring

Status: Ongoing

Product Quantity: 680 units

Code Information:

Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated