Device product
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.
Z-2371-2015
Product summary
- Event
- Event 71543
- Status
- Terminated
- Classification
- Class I
- Quantity
- 609 pieces
- Official record key
device-enforcement:Z-2371-2015
Official wording
Reason: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Code information: P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.
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.
Derived failure modes
-
Unknown
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.