Duet TRS™ Universal Straight and Articulating Single Use Loading Units

Fabricant

  • 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.
  • Source
    DH

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  • Modèle / numéro de série
  • Description du dispositif
    StaplerDuet TRS™ universal straight and articulating single use loading units (SULU)Manufactured by CovidienProduct codes and descriptions of affected devices:Product code   Description DUET4535   Duet TRS™ 45 3.5mm straight SULU DUET4535A   Duet TRS™ 45 3.5mm articulating SULU DUET4548   Duet TRS™ 45 4.8mm straight SULU DUET4548A   Duet TRS™ 45 4.8mm articulating SULU DUET6035   Duet TRS™ 60 3.5mm straight SULU DUET6035A   Duet TRS™ 60 3.5mm articulating SULU DUET6048   Duet TRS™ 60 4.8mm straight SULU DUET6048A   Duet TRS™ 60 4.8mm articulating SULU
  • Manufacturer