GraveFDAEn curso
Puede causar una enfermedad grave o la muerte. No lo coma.
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
La agencia publicó este retiro solo en inglés. El nombre del producto y los códigos del paquete se muestran tal como los escribió la agencia, para que coincidan exactamente con su paquete.
Revise su paquete
Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
- Motivo
- Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- Distribuido
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Empresa
- Fresenius Kabi USA, LLC
- Anunciado
- El retiro comenzó