Device Recall Terumo Threestage Venous Return Cannulae

  • 모델명 / 제조번호(시리얼번호)
    28 Fr with 3/8" flare , Part No., 816460, Lot #:, 0645280, 0649157, 0654734, 0666686, 0674810, 0678724, 0682221, 0684790, 0698319, 0698910; 30 Fr with 3/8" connector , Part No., 820732, Lot #:, 646450 & 30 Fr with 3/8" flare , Part No., 820731, Lot #:, 0689843, 0698323
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. || 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

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA