Device Recall Sarns

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 80001-01 and lot number: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • 제품 설명
    CUSTOM CPB CATHETER KIT-DR. || Product Usage: || The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 121 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.
  • 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 D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer || Product Usage: || The Sarns 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
  • 모델명 / 제조번호(시리얼번호)
    , Part No. 144936, Lot #: 653821
  • 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 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
  • 모델명 / 제조번호(시리얼번호)
    Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 4935, Lot #: 0655206, 0656923, 0682315, 0685669, 0696718; Part No. 4936, Lot #: 0655292, 0665320, 0684443, 0684444, 0687492, 690459R & Part No. 4936X, Lot #: 0656438, 0661606, 683308R.
  • 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 Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector 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
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Part No. 16094, Lot #: 655235
  • 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 Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare || 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
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