Device Recall ARROWgard Blue(R) MAC(TM) TwoLumen Central Venous Access Kit

  • 모델명 / 제조번호(시리얼번호)
    510K # K002507, Material # ASK-21142-HF3
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters || 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
  • 1 Event

제조사

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