Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology

  • Modèle / numéro de série
    1) EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology 3.5MM: Item No. HEM3335 Affected Lots: N7J1145MX, N7K0092MX, N7K0692MX, N7K0693MX, N7L0380MX, N7L0457MX, N7L0594MX, N7L0676MX, N7L0762MX, N7L0868MX, N7L0940MX, N7L1076MX, N7L1077MX, N7M0144MX, N7M018SMX, N7M0732MX, N7M0733MX, N7M0835MX, N8A0144MX, N8A0166MX 2) 4.8 mm Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology Item No. : HEM3348 Affected Lots: N7K0694MX, N7L1078MX, N7M0837MX
  • Description du dispositif
    Staplers, Surgical, Circular, Hemorrhoid
  • Manufacturer
  • 1 Event

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.
  • Représentant du fabricant
    Medtronic Saudi Arabia
  • Source
    SFDA