Data Foundry

Medical device recalls 2015

Alaris Medley LVP Bezel Assembly — Class I medical device recall Z-2372-2015

Terminated recall by Elite Biomedical Solutions LLC, reported 2015-08-26, distributed nationwide. Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

Recall numberZ-2372-2015
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmElite Biomedical Solutions LLC, Cincinnati, OH, United States
Recall initiated2015-06-03
Classified2015-08-19
Reported by FDA2015-08-26
Terminated2017-03-07
DistributedNationwide (US)
Quantity346 units
Lot numbers031815100, 032415100, 04061545, 043015215

Product

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 infusion pump.

Reason for recall

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

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-2372-2015. 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.