Device Recall Premier Guard Sterile Drape

  • Modèle / numéro de série
    Lot Numbers: 1112351 to 1609891
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) || Item Number: 01-0020 || Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA