Events

Rappel de Device Recall AccuGuide

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Xomed, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37298
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0576-2007
  • Date de mise en oeuvre de l'événement
    2007-01-22
  • Date de publication de l'événement
    2007-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50302
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Surface electrodes - Product Code GZX
  • Cause
    A labeling discrepancy was internally identified for the surface electrode component of ref 8263210 accuguide emg injection needle, 30g x 25mm. the outside box label correctly indicates 'content: 5 sterile injection needles and 10 non-sterile surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
  • Action
    Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock. Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.

Device

Device Recall AccuGuide
  • Modèle / numéro de série
    Lot Numbers: 45648300, 46526000, 46709500, 48166300
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    AccuGuide Injection Needles (Surface electrodes) || The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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