Device Recall SJM Peel Away Introducer

  • Modèle / numéro de série
    Lot Number: 2694227.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    OUS only: Belgium.
  • Description du dispositif
    SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. || Intended for use for the introduction of catheters into a vessel.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

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  • Modèle / numéro de série
    Lot Number: 2694252.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    OUS only: Belgium.
  • Description du dispositif
    SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. || Intended for use for the introduction of catheters into a vessel.
  • Manufacturer