BD Alaris System — Class II medical device recall Z-2935-2020
Ongoing recall by CareFusion 303, Inc., reported 2020-09-09, distributed nationwide. Infusion pump component defect may result in interruption of patient monitoring
| Recall number | Z-2935-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2020-08-04 |
| Classified | 2020-09-03 |
| Reported by FDA | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 680 units |
| Serial numbers | 10002682711, 10002720508, 1000287042, 10002882569 |
| Model numbers | 8300, ETCO2 |
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.
Reason for recall
Infusion pump component defect may result in interruption of patient monitoring
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2935-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.