Events

Rappel de Device Recall Medtronic Preimplantation Test Kit,

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 Neurosurgery.

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
    65600
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1810-2013
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • Date de publication de l'événement
    2013-07-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119690
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Cause
    Medtronic neurosurgery is recalling the medtronic preimplantation test kit because the outer carton had expiration dates that were incorrect. the date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
  • Action
    An "Urgent Field Safety Notice" recall letter dated 6/28/13 was sent to customers who purchased the Medtronic Preimplantation Test Kit, catalog number 21047, to inform them of the recall due to the incorrect outer carton expiration dates. The recall letter informed the customers of the problems and actions identified. Customers were instructed to contact the Quality Department at (805) 571-8725 for questions.

Device

Device Recall Medtronic Preimplantation Test Kit,
  • Modèle / numéro de série
    C22929 C40543 C56465 C80034 D16291 C25329 C42910 C57924 C80787 D16693 C25475 C43115 C62128 D00052 D20967 C25662 C43512 C65929 D01033 D22544 C28396 C45615 C66120 D07250 D25802 C29229 C46351 C68906 D07373 D30597 C33946 C46583 C69701 D07507 C36893 C49439 C71003 D10462 C36904 C49706 C73622 D11409 C38718 C51418 C76639 D13208 C39484 C52417 C78186 D14099 C40150 C53058 C79051 D16157
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution in the US.
  • Description du dispositif
    Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Adresse du fabricant
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • 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