Events

Device Recall Spectra Optia Apheresis System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Caridian BCT, Incorporated 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
    58909
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2674-2011
  • 사례 시작날짜
    2010-12-09
  • 사례 출판 날짜
    2011-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100504
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • 원인
    An additional air detection system is being added to all existing systems to detect air in the system's return line.
  • 조치
    CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.

Device

Device Recall Spectra Optia Apheresis System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1P00100 thru 1P00719
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • 제품 설명
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
    Caridian BCT, Incorporated

Manufacturer

Caridian BCT, Incorporated
  • 제조사 주소
    Caridian BCT, Incorporated, 10811 W Collins Ave, Lakewood CO 80215-4440
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA