Events

Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trek Diagnostic Systems 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
    31375
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0708-05
  • 사례 시작날짜
    2005-03-04
  • 사례 출판 날짜
    2005-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-12-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37750
  • 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
    System, Blood Culturing - Product Code MDB
  • 원인
    Blood culture bottles with an error in the bar code on the labels, were shipped.
  • 조치
    The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for replacement.

Device

Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product wa...
  • 모델명 / 제조번호(시리얼번호)
    Lot #144444SA, Expiration Date: 01/2006.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The blood culture bottles were distributed to the following states within the U.S.: MA, NY, TX, OH, MD, KY, OR, MO, NJ, PA, MI, FL, IN, NC, KS, GA, WI, & IL.
  • 제품 설명
    Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.
  • Manufacturer
    Trek Diagnostic Systems

Manufacturer

Trek Diagnostic Systems
  • 제조사 주소
    Trek Diagnostic Systems, 982 Keynote Cir Ste 6, Cleveland OH 44131-1873
  • Source
    USFDA