FDA Device recall Z-2371-2015
Alaris Medley LVP Frame Membrane
- FDA Device
- Class I
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class I recall of Alaris Medley LVP Frame Membrane by Elite Biomedical Solutions, citing administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2371-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-06-03 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elite Biomedical Solutions |
| Distribution | US |
Product
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 infusion pump.
Reason
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Identifiers
| code_info | P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2371-2015%22
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