Device Recall Alaris Pump Module Model 8100

  • Model / Serial
    Model 8100; Lot/Serial numbers-various
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
  • Product Description
    Alaris Pump Module Model 8100 (formerly Medley Pump Module) || Subsequent Product Code: FPA. || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Canada
  • Product Description
    Alaris Pump Module model 8100
  • Manufacturer
  • Model / Serial
    All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.
  • Product Description
    Alaris Pump Module model 8100. || Subsequent product code: FPA || The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
  • Manufacturer