Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device 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
    59184
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2831-2011
  • 사례 시작날짜
    2011-06-27
  • 사례 출판 날짜
    2011-07-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-20
  • 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
    Sheath, Corrugated rubber, for nonindwelling catheter - Product Code NNY
  • 원인
    The kit contains skin-prep protective wipes that were manufactured by the triad group and are being recalled by smith & nephew, due to possible bacterial contamination.
  • 조치
    Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
  • 제품 설명
    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. || Used for urine collection.
  • Manufacturer

Manufacturer

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