Device Recall Elutia Surgical Wound Drain

  • Model / Serial
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one foreign consignee in Lebanon.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • Manufacturer Parent Company (2017)
  • Source
    USFDA