Events

BD Vacutainer Push Button collection Set 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
    56972
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0816-2011
  • 사례 시작날짜
    2010-10-05
  • 사례 출판 날짜
    2010-12-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95082
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • 원인
    There is the possibility for certain lots of the bd vacutainer push button blood collection sets to have separation of the cannula from the hub.
  • 조치
    BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.

Device

BD Vacutainer Push Button collection Set
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 367342; Lot numbers: 0145457, 0152300, 0153981, 0153982, 0158081, 0158082, 0158084, 0160664, 0160666, all exp 5/31/2012; Lot numbers 0165202, 0165205, 0165207, 0165218, 0165226, 0165227, 0165232, 0165234, 0176872, 0179208, 0179209, 0179212, 0180023, 0180026, 0180027, 0180028, 0180040, 0180042, all exp 6/30/2012; Lot numbers 0196209, 0196210, 0201399, 0201400, 0201402, 0208593, 0211641, all exp 7/31/2012.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    BD Vacutainer Push Button collection Set; || Non-Pyrogenic, Sterile, Rx only; || 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) || Becton Dickinson & Co., Franklin Lakes, NJ, USA || Intended use: Blood collection
  • 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