Device Recall Boston Scientific Platinum Plus Guidewire

  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372, 7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137, 8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172, 8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876, 8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846, 8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277, 8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109, 8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348, 8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353, 9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695, 9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417, 9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092, 9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945, 9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493, 9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198, 11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322, 11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418, 11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614, 11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911, 11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605, 11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997, and 11632322.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 7908999, 7945613, 7968042, 8002696, 8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907, 8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757, 8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733, 9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772, 11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154, and 11665770
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696, 8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162, 8432959, 8506417, 8533771, and 11643756.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer