Events

Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet 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
    35201
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0913-06
  • 사례 시작날짜
    2006-05-01
  • 사례 출판 날짜
    2006-05-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45532
  • 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
    Biopsy Needle - Product Code FCG
  • 원인
    Manufacturing change that has introduced variability in the length of the inner stylet. when the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
  • 조치
    Recall letters were sent to all consignees (Radiology Department Manager with a copy to the Hospital Administrator) via Federal Express overnight delivery with signature receipt required on May 1, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV).

Device

Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet
  • 모델명 / 제조번호(시리얼번호)
    Lot # REP JO196
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed to the following five states: 1) California, 2) Florida 3) New Jersey, 3) Missouri, 4) Texas, 5) Washington. The product was also distributed to Canada and Latin America. Note: units distributed to Latin America remained in Bard''s distribution system and have been returned.
  • 제품 설명
    Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. || The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc