Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml. 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
    29531
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1319-04
  • 사례 시작날짜
    2004-07-02
  • 사례 출판 날짜
    2004-08-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2004-12-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar - Product Code JSO
  • 원인
    Sheep blood products may be contaminated with a brucella species (b. ovis).
  • 조치
    Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail. Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04). Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return. Response forms will be reconciled. Distribution of the affected lots ceased on 7/1/04. Customers are asked to discard their inventory.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number: 4155332 and Expiration date: June 29, 2004
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.
  • 제품 설명
    Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
  • Manufacturer

Manufacturer