Events

Diamondback 360 Orbital Atherectomy Device 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
    52810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2028-2009
  • 사례 시작날짜
    2009-04-16
  • 사례 출판 날짜
    2009-09-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84051
  • 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
    Catheter, peripheral, atherectomy - Product Code MCW
  • 원인
    Csi is correcting (8) packages of diamondback 360 due to a missing "use by date" on the device labeling. the labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. the units affected by this correction are sterilized products, and csi believes that there is no immediate risk to health associated with these distributed products recognizing the valid s.
  • 조치
    Cardiovascular System, Inc. issued an "URGENT: Medical Device Correction" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the "Device" re-labeling would be performed by company representatives. Devices will not be returned. For further information, contact Cardiovascular System, Inc. 1-877-274-0901.

Device

Diamondback 360 Orbital Atherectomy Device
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 23181.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
  • 제품 설명
    Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 || Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. || The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.
  • 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