Device Recall Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers

  • 모델명 / 제조번호(시리얼번호)
    Schein product code 629-3169, Model CL*EE12NLA, lot number 040116; Schein product code 629-8232, Model CL*EE15NLA, lot number 031212; Schein product code 629-5106, Model CL*E20NLA, lot numbers 031128, 0311281223, 031223;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Puerto Rico
  • 제품 설명
    Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Asahi Medical Co Ltd, 1-1 Uchiauwaicho,1-Chome, 14 Flr, Imperial Tower Bldg, Chiyoda Ku Japan
  • Source
    USFDA