Device Recall ICU STAT 2

  • 모델명 / 제조번호(시리얼번호)
    Lot # 2801951
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • 제품 설명
    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot # 2768416
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • 제품 설명
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set || w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot # 2768417
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • 제품 설명
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set || w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • 제품 설명
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer