Device 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.
Z-2372-2015
Product summary
- Event
- Event 71543
- Status
- Terminated
- Classification
- Class I
- Quantity
- 346 units
- Official record key
device-enforcement:Z-2372-2015
Official wording
Reason: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Code information: P/N 49000204 Lot #'s 031815100, 032415100, 04061545 and 043015215
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.