Device Recall Sarns Malleable Venous Return Cannulae

  • 모델명 / 제조번호(시리얼번호)
    Part No. 4881, Lot #: 0646527, 0652247, 0655237, 0657761, 0659431, 0663547, 0666625, 0674022, 0676975, 0678722, 0681793, 0693318, 0695683, 0697379; Part No. 4881X, Lot #: 684032; Part No. 4882, Lot #: 0646526, 0649165, 0650782, 0653857, 0657248, 0662811, 0668349, 0673863, 0676584, 0678953, 0682571, 0683601, 683601R; Part No. 4882X, Lot #: 0651693, 0656946, 0668566, 0683306, 683306R; Part No. 4883, Lot #: 0647472, 0653433, 0658525, 0659432, 0662541, 0673755, 0676593, 0681816, 0691567, 0696613; Part No. 4883X, Lot #: 0649154, 0653823, 0675680; Part No. 4884, Lot #: 0646143, 0647046, 0649882, 0652246, 0654605, 0662807, 0667262, 0670484, 0674103, 0677804, 0683383, 0683605, 0692771, 0696611; Part No. 4884X, Lot #: 0649169, 0653445, 0683608; Part No. 4885, Lot #: 0647474, 0652803, 0655236, 0662804, 0670673, 0675804, 0677976, 0681127, 0695872, 0698980; Part No. 4885X, Lot #: 0652526, 0662887; Part No. 4886, Lot #: 0659433, 0661555, 0667893, 0669797, 0681817; Part No. 4886X, Lot #: 652528 & Part No. 4887, Lot #: 0661530, 0668567, 0672138.
  • 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
    Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating || Product Usage: The 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