Device Recall Cellex Photopheresis System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Therakos 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
    73012
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1322-2016
  • 사례 시작날짜
    2015-12-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-10-14
  • 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
    System, photopheresis, extracorporeal - Product Code LNR
  • 원인
    The mallinckrodt (therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of kits from lot d 342.
  • 조치
    Therakos sent an Urgent Medical Device Recall letter dated December 23, 2015, to all affected customers by UPS Overnight Mail. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to immediately identify, discontinue use and return affected product. Customers with questions were instructed to call Therakos Customer Service at 1-855-422-9115, option 4. For questions regarding this recall call 908-238-6813.

Device

  • 모델명 / 제조번호(시리얼번호)
    Mfr lot #D342
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.
  • 제품 설명
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. || Manufacturing lot D342 || UDI: 20705030200003 || The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
  • Manufacturer

Manufacturer

  • 제조사 주소
    Therakos Inc, 10 N High St, West Chester PA 19380-3003
  • 제조사 모회사 (2017)
  • Source
    USFDA