Device Recall FREEDOMAIRE(R) HELMET SYSTEM WITH BELT

  • Model / Serial
    Lot Numbers: C9272 and C10078
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) Distribution.
  • Product Description
    FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, 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

Manufacturer

  • Manufacturer Address
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Manufacturer Parent Company (2017)
  • Source
    USFDA