Device Recall Endobronchial Tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 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
    52823
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1940-2009
  • 사례 시작날짜
    2009-07-31
  • 사례 출판 날짜
    2009-09-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Connector, airway (extension) - Product Code BZA
  • 원인
    The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
  • 조치
    Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 5-15301, Lot Numbers: 1132962, 1135424, 1136773, 1169645, 1173522, 1178399, 1188200, 1186993, 1194489,1201020, 1212344, 1258338, 1269036, 01L0700243, 01A0800245, 01C0800104, 01E0800341, 01F0800283, 01F0800354, 01L0800005, 01M0800250 and 01A0900036; and   Catalog Number: 5-15401, Lot Numbers: 1152620, 1153518, 1153626, 1155031, 1156400, 1156986, 1157666, 1160298, 1164076, 1169644, 1168080, 1172007, 1173521, 1182297, 1186762, 1193750, 1195118, 1276554, X1198365, X1198635, 01B0800103, 01F0800284, 01G0800362, 01H0800175, 01J0800015, 01A0900367 and 01D0900087.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
  • 제품 설명
    Hudson RICA¿ Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. || Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • 제조사 모회사 (2017)
  • Source
    USFDA