Device Recall OptiSeal Valved PTFE Peelable Introducer

  • Modelo / Serial
    Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: United States, including the states of MN and CA.
  • Descripción del producto
    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA