Device Recall Drainage Bag

  • Modelo / Serial
    Lot numbers: 082943, 083375, 083302, 083232 and 100904.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA