Device Recall Elutia Surgical Wound Drain

  • 모델명 / 제조번호(시리얼번호)
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to one foreign consignee in Lebanon.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • 제조사 모회사 (2017)
  • Source
    USFDA