Events

Device Recall STERRAD 100NX 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    66815
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0402-2014
  • 사례 시작날짜
    2013-11-11
  • 사례 출판 날짜
    2013-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123534
  • 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
    Sterilizer, chemical - Product Code MLR
  • 원인
    Advanced sterilization products (asp) is recalling the sterrad nx and sterrad 100nx sterilization systems because asp has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in sterrad systems.
  • 조치
    Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notificaiton letter on November 11, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. Customers were instructed to provide the notice to anyone in their facility that needs to be informed and post this notice where appropriate. Customers were instructed to contact ASP at 1-888-783-7723 for any suspected problems. ASP is collaborating with KARL STORZ Endoskope to determine the sterilization impact of the suction port lumen material. Customers are instructed to contact KARL STORZ Endoskope Technical Support at (800)421-0837, ext 5350 for alternative reprocessing instructions. For questions regarding this recall call 949-453-6400.

Device

Device Recall STERRAD 100NX
  • 모델명 / 제조번호(시리얼번호)
    Please refer to consignee list
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    STERRAD 100NX, Product Code: 10104 || The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA