Device Recall Y Type Blood Pump Sets

  • Model / Serial
    Product numbers IV-85001-AAMC and IV-85020-UW.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
  • Product Description
    Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and with Two Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Polysulfone Stopcocks. || An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Product numbers MPI-17894, MPI-17895, MPI-17897, MPI-17899, MPI-17927, and MPI-18054.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
  • Product Description
    Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. || An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
  • Manufacturer