Z-2371-2015 Class I Terminated

Recalled by Elite Biomedical Solutions LLC — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
June 3, 2015
Termination Date
March 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
609 pieces

Product Description

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 for Recall

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

Distribution Pattern

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.

Code Information

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