Devices

Medtronic

  • Modelo / Serial
    Lot number begins 508xxxx or lower
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.
  • Descripción del producto
    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove || Catalog Numbers/Description: || 573208 7519-DHCG MINOR KIT || 573210 7581-CSD Minor KIT || 573741 7667-HMI Minor Kit || 31144507 7519 Minor Surgical Kit || 573830D MINOR KIT
  • Manufacturer
    Covidien LLC
  • 3 Events

Fabricante

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

829 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Medtronic MiniMed Paradigm Silhouette and SureT infusion sets
  • Modelo / Serial
    This field correction involves all models of Silhouette and Sure-T insulin infusion sets.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lativa, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • Descripción del producto
    Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
  • Manufacturer
    Medtronic MiniMed Inc.
Medtronic Clip Gun™ Scalp Clip System
  • Modelo / Serial
  • Descripción del producto
    Medtronic: Medtronic Clip Gun™ Scalp Clip System
  • Manufacturer
    Medtronic
Medtronic HeartWare™ HVAD™ Battery Charger
  • Modelo / Serial
  • Descripción del producto
    Medtronic: Medtronic HeartWare™ HVAD™ Battery Charger
  • Manufacturer
    Medtronic
Medtronic HeartWare™ HVAD™ System
  • Modelo / Serial
  • Descripción del producto
    Medtronic: Medtronic HeartWare™ HVAD™ System
  • Manufacturer
    Medtronic
Medtronic MiniMed 640G insulin pump
  • Modelo / Serial
  • Descripción del producto
    Medtronic: Medtronic MiniMed 640G insulin pump
  • Manufacturer
    Medtronic
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