Device Recall Sarns Flexible Aortic Arch Cannulae

  • Model / Serial
    , Part No. 144936, Lot #: 653821
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
  • Product Description
    Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector || Product Usage: || The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
  • 1 Event

Manufacturer

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