Device Recall FREEDOMAIRE(R) HELMET WITH MOTOR MODULE

  • Modèle / numéro de série
    Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) Distribution.
  • Description du dispositif
    FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX || The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Société-mère du fabricant (2017)
  • Source
    USFDA