Devices

Device Recall Elutia Surgical Wound Drain

  • Modèle / numéro de série
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to one foreign consignee in Lebanon.
  • Description du dispositif
    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

Fabricant

Bacterin International, Inc.
  • Adresse du fabricant
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • Société-mère du fabricant (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA