Drug recall
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
FDA recall event 85691 · Class I · CareFusion 303, Inc.
Key facts
| Event ID | 85691 |
|---|---|
| Recall numbers | Z-2716-2020, Z-2717-2020, Z-2718-2020, Z-2719-2020, Z-2720-2020, Z-2721-2020, Z-2722-2020, Z-2723-2020 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system, Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system, Alaris PCA Module Model 8120, a modular infusion pump and monitoring system, Alaris Pump Module Model 8100, a modular infusion pump and monitoring system, Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system and 3 more |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with… |
| Initiation date | Jun 30, 2020 |
| Report date | Aug 12, 2020 |
| Termination date | Apr 22, 2024 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2016493 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: