Events

Device Recall Silicone CTS Tracheostomy Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arcadia Medical Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58828
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2657-2011
  • 사례 시작날짜
    2011-05-08
  • 사례 출판 날짜
    2011-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100382
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Tracheostomy tube (w/wo connector) - Product Code BTO
  • 원인
    The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. this eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
  • 조치
    Arcadia Medical Corporation sent a "MEDICAL DEVICE RECALL" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.

Device

Device Recall Silicone CTS Tracheostomy Tube
  • 모델명 / 제조번호(시리얼번호)
    Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania
  • 제품 설명
    Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, || Provides direct tracheal access for airway management || Arcadia Medical Corporation || 1450 East American Lane, Schaumburg, IL 60173 USA || Arcadia Medical Corporation Tortola, British Virgin Islands || www.arcadiamedical.com, Made in USA
  • Manufacturer
    Arcadia Medical Corporation

Manufacturer

Arcadia Medical Corporation
  • 제조사 주소
    Arcadia Medical Corporation, 1140 Millennium Dr, Crown Point IN 46307-7533
  • Source
    USFDA