Events

Device Recall Diamondback 360, CSI ViperWire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiovascular Systems, Inc. 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
    51499
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1250-2009
  • 사례 시작날짜
    2009-03-16
  • 사례 출판 날짜
    2009-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80555
  • 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
    Peripheral Catheter Atherectomy - Product Code MCW
  • 원인
    Csi is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. the labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
  • 조치
    Customer letters were FedEx'd to CSI Sales Professionals on 03/16/2009, who delivered the letters and helped coordinate the removals of affected product. The letter identified the product, provided a description of the issue and provided instructions to immediately remove from use and return the affected guidewires to CSI. A Customer Acknowledgement Form was asked to be completed and returned with the devices.

Device

Device Recall Diamondback 360, CSI ViperWire
  • 모델명 / 제조번호(시리얼번호)
    Lot: P1406641
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • 제조사 주소
    Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
  • 제조사 모회사 (2017)
    Cardiovascular Systems Inc.
  • Source
    USFDA