Device Recall Drainage Bag

  • Modèle / numéro de série
    Lot numbers: 082943, 083375, 083302, 083232 and 100904.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Société-mère du fabricant (2017)
  • Source
    USFDA