Device Recall CPB Catheter Kit

  • Model / Serial
    Part No. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09
  • 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
    CPB Catheter Kit || Product Usage: || Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
  • Manufacturer
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.
  • 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
    CPB CATHETER KIT- DR.VAN TRIGHT. || The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
  • Manufacturer