Events

UltraClip Dual Trigger breast tissue marker 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Peripheral Vascular 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
    65046
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1524-2013
  • 사례 시작날짜
    2013-04-16
  • 사례 출판 날짜
    2013-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117792
  • 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
    Clip, implantable - Product Code FZP
  • 원인
    Bard peripheral vascular (bpv) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.
  • 조치
    Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.

Device

UltraClip Dual Trigger breast tissue marker
  • 모델명 / 제조번호(시리얼번호)
    Affected Product Lots with the following Product Code and Lot Number combinations.   Product Code  864017D  864017D  864017D  864017D  864017D  864017D  864017D  864017DL   Lot Number   HUWI1522   HUWI1941   HUWI1942   HUWI1943   HUWJ1851   HUWJ1852   HUWK0350   HUWJ1610
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA Nationwide and Internationally to Europe.
  • 제품 설명
    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. || Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • 제조사 주소
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA