Drug recall
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's…
FDA recall event 71543 · Class I · Elite Biomedical Solutions LLC
Key facts
| Event ID | 71543 |
|---|---|
| Recall numbers | Z-2371-2015, Z-2372-2015 |
| Recalling firm | Elite Biomedical Solutions LLC |
| Product type | Devices |
| Products | Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100…, Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. |
| Initiation date | Jun 3, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | Mar 7, 2017 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 3009712113 |
At a glance
- 1–9 Products in this recall
- 1–9 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: