Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit

  • Modèle / numéro de série
    Lot number 08-TM-51
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Description du dispositif
    Flexi-Seal Fecal Management System Advanced Odor Control Kit. || Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 || ConvaTec || Skillman, NJ || Made in USA with imported components || "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool."
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558
  • Société-mère du fabricant (2017)
  • Source
    USFDA