Events

Device Recall BBL Port A Cul Tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    69954
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1746-2015
  • 사례 시작날짜
    2014-11-21
  • 사례 출판 날짜
    2015-06-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132022
  • 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
    Patient sample collection containers - Product Code N/A
  • 원인
    The products may exhibit indications of excessive oxidation. excessive oxidation may affect the viability of anaerobic microorganisms.
  • 조치
    BD Diagnostic Systems sent an Urgent Product Recall letter dated December 2014 to all affected customers. Recall notification was initiated on November 21, 2014, the notification was sent by fax and letters by UPS. Customer notification for the expansion of the recall was initiated on December 18, 2014, the notification was sent by fax and letters by UPS. For questions regarding this recall call 800-638-8663.

Device

Device Recall BBL Port A Cul Tubes
  • 모델명 / 제조번호(시리얼번호)
    Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date  221606 4042455 2/25/2014 2/5/2015 221606 4067180 3/18/2014 3/5/2015 221606 4087204 4/10/2014 3/25/2015 221606 4124702 5/8/2014 4/24/2015 221606 4161968 7/7/2014 6/12/2015 221606 4181959 7/14/2014 7/3/2015 221606 4032407 2/14/2014 1/29/2015 221606 4042069 2/17/2014 2/4/2015
  • 유통
    US Nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • 제품 설명
    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA