Device Recall SPECIALTYCARE HUDGENS.

  • Model / Serial
    Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.
  • Product Description
    SPECIALTYCARE - HUDGENS. || The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA