CLASS II ONGOING Device recall · Reported 9 Sep 2020 · FDA Enforcement Report

BD Alaris System recalled by CareFusion 303

CareFusion 303 is recalling BD Alaris System, distributed nationwide in the US. The recall was initiated on 4 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569

Quantity recalled680 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2935-2020
FDA event ID: 85997
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Aug 2020
FDA classified: 3 Sep 2020
Reported: 9 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

4 Aug 2020	Recall initiated by company
3 Sep 2020	Classified by FDA	+30 days
9 Sep 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Infusion pump component defect may result in interruption of patient monitoring

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California Florida Georgia Iowa Idaho Illinois Kansas Louisiana Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska Nevada New York Ohio Pennsylvania

Questions about this recall

Is BD Alaris System recalled?

Yes. CareFusion 303 recalled BD Alaris System on 4 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-2935-2020.

Why was it recalled?

Infusion pump component defect may result in interruption of patient monitoring

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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