Device Recall 28 cm (11") PUR Bifuse Ext Set

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 3303906. Item No. 011-AM6116
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
  • 제품 설명
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. || Product Usage: || The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • 제조사 모회사 (2017)
  • Source
    USFDA