Devices

Boston Scientific Equalizer Balloon Catheter

  • Modèle / numéro de série
    Lot: 11637077, 11676784, 11740302, 11811184, 11864634, 11889228, 11960754, 12043982, 12156054, 12170193, 12240685, 12240686, 12311172, 12363749, 12397168, 12397177, 12442594, 12442595, 12490333, 12512652, 12530896, 12535289, 12535290, 12556163, 12567338, 12567339, 12582186, 12603422, 12605776, 12652788, 12652791, 12720339.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Description du dispositif
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricant

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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

3 dispositifs médicaux avec un nom similaire

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Boston Scientific Equalizer Balloon Catheter
  • Modèle / numéro de série
    Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Description du dispositif
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter
  • Modèle / numéro de série
    Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Description du dispositif
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter
  • Modèle / numéro de série
    Lot: 12156055, 12186592, 12186593, 12186594, 12186596, 12186599, 12227670, 12227671, 12274315, 12303573, 12322322, 12330756, 12330757, 12331003, 12331005, 12331006, 12331007, 12331008, 12368967, 12379423, 12383688, 12397162, 12442599, 12442640, 12442780, 12459665, 12459666, 12526737, 12535281, 12535282, 12535283, 12535284, 12582188, 12605774, 12617283, 12687684, 12702148, 12702149, 12702553.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Description du dispositif
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation