Device Recall Engenex BioDome Easy Release Dressing Kit, XL

  • Modèle / numéro de série
    Lot number 0709101, Exp 9/2009; lot number 0710101, exp 10/2009.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; || Advanced Negative Pressure Wound Therapy System; || Sterile, box contains 15 units; || Boehringer Wound Systems, LLC, Norristown, PA 19404 || Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.
  • Manufacturer
  • 1 Event

Fabricant

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