Events

BD Visitec EdgeAhead MVR Knife 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson and Company 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
    55254
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1597-2010
  • 사례 시작날짜
    2010-04-06
  • 사례 출판 날짜
    2010-05-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90421
  • 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
    Knife, ophthalmic - Product Code HNN
  • 원인
    A field action was initiated due to a recent customer complaint from japan there is a labeling mixup and that some of the bd visitec edgeahead mvr knife 0.90mm (20g), ref 585230, shelf packs may contain bd visitec edgeahead slit knife 2.3mm (40 degree), ref 8009918.
  • 조치
    BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm. For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at ahusebo@bd.com.

Device

BD Visitec EdgeAhead MVR Knife
  • 모델명 / 제조번호(시리얼번호)
    Model # 585230, Lot 9202221
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada and Japan.
  • 제품 설명
    BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. || Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company
  • 제조사 주소
    Becton Dickinson and Company, 411 Waverley Oaks Rd Ste 2229, Waltham MA 02452-8448
  • Source
    USFDA