Device Recall ARROWgard Blue MAC

  • 모델명 / 제조번호(시리얼번호)
    CDA-21242-1A 13F16L0209 13F17F0437
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US in the states of OH, FL, SC, TX, KY, NJ, MI
  • 제품 설명
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit || Product Usage: || The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A  Device Listing D025768
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Canada
  • 제품 설명
    1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || 2) ARROWg+ard Blue PSI Kit || 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit || 4) ARROWg+ard Blue PSI Kit || The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
  • Manufacturer