Devices

Device Recall Elutia Surgical Wound Drain

  • Modelo / Serial
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to one foreign consignee in Lebanon.
  • Descripción del producto
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" || Two different sizes, 10 units per box: || 19 Fr Round Hubless part number 7110; || 24 Fr Round Hubless part number 7118. || AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
  • Manufacturer
    Bacterin International, Inc.
  • 1 Event

Fabricante

Bacterin International, Inc.
  • Dirección del fabricante
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • Empresa matriz del fabricante (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA