Events

Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube 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
    64494
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1056-2013
  • 사례 시작날짜
    2013-02-14
  • 사례 출판 날짜
    2013-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116319
  • 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
    Container, specimen, sterile - Product Code FMH
  • 원인
    The bd vacutainer urinalysis transfer straw kit #364991, lot 1335484 has preprinted polybags which are incorrectly labeled as catalog #364953. bd advises any customer who purchased this kit that the tube in this kit is not a c&s; tube. if a customer relies solely on the polybag labeling and uses the tube inside the kit for the purpose of collecting urine for culture and sensitivity, it is possible.
  • 조치
    BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.

Device

Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube
  • 모델명 / 제조번호(시리얼번호)
    Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
  • 제품 설명
    BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, || The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
  • 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