Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)

  • 모델명 / 제조번호(시리얼번호)
    Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. || Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
  • Source
    USFDA