Device Recall Dolphin Inflation Device

  • Model / Serial
    Lot Number 15125173
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to MD, NY, and IL
  • Product Description
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
  • Source
    USFDA