FDA Device recall Z-2935-2020
BD Alaris System
- FDA Device
- Class II
- ongoing
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of BD Alaris System by Carefusion 303, citing infusion pump component defect may result in interruption of patient monitoring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2935-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-04 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | US |
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
Infusion pump component defect may result in interruption of patient monitoring
Identifiers
| code_info | Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2935-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.