Elite Biomedical Solutions LLC recalls Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal c…

Recall date

June 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2371-2015

FDA classification

Class I

Brand / firm

Elite Biomedical Solutions LLC

Sold / distributed

Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.