Devices

Device Recall Medstorm Adult Radiolucent LeadsOut Electrode

  • Modèle / numéro de série
    Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
  • Manufacturer
    Heart Sync, Inc
  • 1 Event

Fabricant

Heart Sync, Inc
  • Adresse du fabricant
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Société-mère du fabricant (2017)
    Heart Sync, Inc
  • Source
    USFDA