The Recall Desk
CriticalFDA (Devices)·Z-2372-2015·Announced 2015-08-26

Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the defect has the potential to cause injury or death, and the agency classification is FDA Class I, which meets the criteria for a Critical severity score.

Plain-English summary

Elite Biomedical Solutions LLC is recalling 346 units of the Alaris Medley LVP Bezel Assembly. This component is used in the Alaris Medley LVP 8100 infusion pump to hold the platen assembly and protect internal components from fluid intrusion. The affected units are identified by Part Number 49000204 and Lot Numbers 031815100, 032415100, 04061545, and 043015215.

The recall was initiated because the defect can result in the administration of inappropriate quantities of fluid. According to the FDA, this malfunction has the potential to cause injury or death to patients. The agency has classified this as a Class I recall, which is the most serious type of device recall.

The affected products were distributed nationwide in the states of Arizona, California, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. Healthcare facilities and users should stop using the affected bezel assemblies and contact Elite Biomedical Solutions LLC for instructions on replacement or repair.

The recalled product

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.
Manufacturer
Elite Biomedical Solutions LLC
Category
Medical Device — Infusion Pump Component
Hazard
Affected units
346

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • P/N 49000204 Lot #'s 031815100
  • 032415100
  • 04061545 and 043015215

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Elite Biomedical Solutions LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Elite Biomedical Solutions LLC

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Same hazard · fluid administration error

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