Devices

Device Recall Pulsavac

  • Modèle / numéro de série
    Lot Numbers: 60650389, 60693321, 60708442, 60778376, 60788853, and 60809433.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
  • 1 Event

Fabricant

Zimmer Orthopaedic Surgical Products
  • Adresse du fabricant
    Zimmer Orthopaedic Surgical Products, 200 W Ohio Ave, Dover OH 44622-9642
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

9 dispositifs médicaux avec un nom similaire

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Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60613025, 60617428, 60622532, 60626631, 60629996, 60633951, 60640534, 60650384, 60652419, 60656841, 60661592, 60661594, 60666491, 60666492, 60671448,  60671449, 60676102, 60693310, 60693311, 60693314, 60693315, 60693326, 60693327, 60694265, 60694266, 60698941, 60703269, 60709912, 60715481, 60723866,  60725488, 60733552, 60733553, 60737816, 60737817, 60739957, 60739958, 60744533, 60744534, 60750514, 60750515, and 60758733
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60607940, 60612145, 60612148, 60613026, 60613027, 60613028, 60613029, 60613030, 60617429, 60617430, 60617431, 60617432, 60617433, 60622534, 60622535, 60622536, 60622537, 60626632, 60626633, 60626634, 60626635, 60626636, 60629997, 60629998, 60629999,  60630001, 60630002, 60633952, 60633953, 60633954, 60633955, 60640536, 60640537, 60640538, 60640539, 60640540, 60642559, 60642560, 60642561, 60642562, 60642563, 60650385, 60650386, 60650387, 60650388, 60652362, 60652363, 60652364, 60652365, 60652367, 60652368, 60652369, 60652421, 60652422, 60652424, 60652425, 60652426, 60652427, 60652429, 60661596, 60661598, 60661601, 60661604, 60661609, 60661616,  60666494, 60666495, 60693316, 60693317, 60693318,  60693319, 60693328, 60693329, 60693331, 60693332,  60693333, 60693334, 60694267, 60694268, 60694269,  60694270, 60694271, 60694272, 60698942, 60698943, 60698944, 60698945, 60698946, 60698947, 60703274, 60703276, 60703289, 60703301, 60703303, 60708431,  60708432, 60708433, 60708435, 60708437, 60709913, 60709914, 60709915, 60709916, 60709918, 60709988, 60715482, 60715484, 60715485, 60715487, 60715488, 60715490, 60723867, 60723868, 60723869, 60723870, 60723873, 60723874, 60723875, 60725490, 60725491, 60725493, 60725494, 60725496, 60733554, 60733555,  60733556, 60733557, 60733558, 60737818, 60737819,  60737820, 60737821, 60739959, 60739960, 60739961,  60739962, 60739963, 60744536, 60744537, 60744538,  60744539, 60750517, 60750520, 60750523, 60750526, 60758734, 60758735, 60758736, 60758737, 60758738, 60758739, 60758740, 60768263, 60768268, 60768269 60768270, 60768271, 60768272, 60769241, 60769242,  60769243, 60769244, 60769245, 60778396, 60778397,  60778398, 60778399, 60782132, 60782133, 60782134,  60782135, 60782136, 60784396, 60784397, 60784398,  60784401, 60784403, 60788880, 60788881, 60788882,  60788883, 60788884, 60795133, 60795140, 60795141,  60795142, 60802487, 60802488, 60802489, 60802490,  60802491, 60802492, 60804280, 60804281, and 60804282.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60626637, 60652433, 60671457, 60693320, 60698948, 60708439, 60715492, and 60725499
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60612157, 60612160, 60613031, 60613032, 60617434, 60617435, 60622538, 60626638, 60630003, 60630004, 60633956, 60633957, 60633958, 60640541, 60640542, 60642564, 60642565, 60642566, 60650390, 60650391, 60652435, 60656852, 60656853, 60656854, 60661621, 60661622, 60661623, 60666504, 60666506, 60693313, 60693322,  60693323, 60693336, 60693338, 60693340, 60694275,  60694276, 60694278, 60698949, 60703306, 60708444, 60709920, 60715493, 60723876, 60725500, 60733559, 60733560, 60737822, 60737823, 60739964, 60739965, 60744540, 60744542, 60750527, 60750528, 60758741,  60758742, 60768273, 60768274, 60769247, 60769248, 60778401, 60778402, 60782137, 60782138, 60784405 60784407, 60788885, 60788886,and 60795145.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products
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