FDAClass IAugust 26, 2015

Alaris Medley LVP Frame Membrane. Intended use to hold recall

Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion.…

Why was Alaris Medley LVP Frame Membrane. Intended use to hold recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.

Product
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion.…
Recalling firm
Elite Biomedical Solutions LLC
Quantity
609 pieces
Distribution
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.
Recall date
August 26, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls