Sheridan T.T.X. Tracheal Tube Exchanger, Large Size 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
    36426
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0129-2007
  • 사례 출판 날짜
    2006-11-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-08-12
  • 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
    Tracheal Tube exchanger - Product Code LNZ
  • 원인
    Biological indicator failed. investigation eliminated all equipment and product related factors.
  • 조치
    Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

  • 모델명 / 제조번호(시리얼번호)
    catalog number (REF) 5-24006, lot number 1189037
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
  • 제품 설명
    Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm - 10.0 mm; a Rx, sterile, single use tracheal tube exchanger; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-24006
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA