Events

Device Recall BD 30G1/2 PrecisionGlide Needle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & 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
    56663
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0023-2011
  • 사례 시작날짜
    2010-08-24
  • 사례 출판 날짜
    2010-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94201
  • 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
    Image-Intensified Fluoroscopic X-Ray System. - Product Code GAA
  • 원인
    There have been reports of blocked/clogged needles for the 30 gauge precisionglide needles.
  • 조치
    BD sent out Product Correction letters to all end users of the product on 8/24/10. Letters were mailed by BD via UPS second day air. The letter stated the issue and said that customers should assess the patency prior to injection. The letter also stated that a BD 30 gauge PrecisionGlide Needle from another lot can be used in place of a clogged needle. If customers require replacement needles or further assistance, they can contact BD at 1-888-237-2762. Finally, the letter states that BD has implemented corrective actions to reduce the potential for further recurrence of the blockage issue.

Device

Device Recall BD 30G1/2 PrecisionGlide Needle
  • 모델명 / 제조번호(시리얼번호)
    Lot number 9057615
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    BD 30G1/2 PrecisionGlide¿ Needle;Catalog/Lot Number: 305106. || Needles are intended for use in aspiration and injection of medications.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA