Events

Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun Medical, Inc. 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
    49565
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0199-2009
  • 사례 시작날짜
    2008-09-17
  • 사례 출판 날짜
    2008-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-05-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73817
  • 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
    Intravascular Administration Set - Product Code FPA
  • 원인
    Product was assembled incorrectly and connected to the wrong part.
  • 조치
    The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.

Device

Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra
  • 모델명 / 제조번호(시리얼번호)
    Item number 474515. Lot number 0061014615 exp 6/30/2013
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
  • 제품 설명
    Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.