Device Recall Drainage Bag

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 082943, 083375, 083302, 083232 and 100904.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005. || The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • 제조사 모회사 (2017)
  • Source
    USFDA