Covidien Ltd.

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.
  • Représentant du fabricant
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
  • Source
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    Surgical Stapler, ROTICULATOR™ Single Use Stapler Ref# Product description 017612 ROTICULATOR™ 55-3.5 Single Use Stapler 017614 ROTICULATOR™ 55-4.8 Single Use Stapler 017615 ROTICULATOR™ 30-3.5 Single Use Stapler 017617 ROTICULATOR™ 30-4.8 Single Use Stapler 017619 ROTICULATOR™ 30-V3 Single Use Stapler Any Lot # starts with the following must be retrained: P7E, P7F, P7G, P7H, P7J, P7K, P7L, P7M, P8A, P8B, P8C, P8D, P8E , P8F, P8G, P8H, P8J, P8K, P8L, P8M, P9A, P9B, P9C, P9D, P9E , P9F, P9G, P9H, P9J, P9K, P9L, P9M, P0A, P0B, P0C, P0D, P0E , P0F, P0G, P0H, P0J, P0K, P0L, P0M, P1A, P1B, P1C, P1D, P1E , P1F, P1G, P1H, P1J, P1K, P1L, P1M, P2A, P2B0153X
  • Description du dispositif
    Surgical, Single Use Stapler