Device Recall Oxygen Sensor 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
    53937
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0585-2010
  • 사례 시작날짜
    2009-11-25
  • 사례 출판 날짜
    2009-12-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-07
  • 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
    Analyzer, Gas, Oxygen, Gaseous-Phase - Product Code CCL
  • 원인
    Sensor causes the oxygen monitor to display prematurely a low sensor warning which indicates an early maintenance requirement for the instrument. this may result in interrupted treatment.
  • 조치
    Consignees were notified via next day delivery on or about 11/25/2009. Each customer received a letter requesting acknowledgement of the recall and a request to return the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second and third mailing to non-responding customers on the consignee list will be made, or as an alternative, the third contact may be by phone, e-mail, or fax. Affected products received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. Records of contacts and of destruction or rework will be maintained. Questions are directed to the company at 1-866-246-6990.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 5804, Lot numbers 906018 and 906003.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    FL, KY, MI, OH, PA, SD, TN, Australia and Canada.
  • 제품 설명
    Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
  • Manufacturer

Manufacturer

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