Events

Rappel de ReliOn

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 Covidien LP.

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
    49606
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0284-2009
  • Date de mise en oeuvre de l'événement
    2008-10-09
  • Date de publication de l'événement
    2008-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73902
  • 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
    Insulin Syringe - Product Code FMI
  • Cause
    Mislabeled: package labeled as an insulin syringe for use with u-100 insulin contains an insulin syringe for use with u-40 insulin. risk of overdose of insulin.
  • Action
    Tyco Healthcare Group LP (Covidien) notified Can-Am Care, Corp. by letter sent by e-mail and by Federal Express on 10/9/08. The letter requests that they immediately inventory, quarantine any remaining stock they may have of the product, return, and notify their customers. Wal-Mart conducted a consumer mailing on October 14, 2008, and is posting placards in their stores. Can-Am Care, whose name appears on the label of the product has concurrently posted a recall notice on their website.

Device

ReliOn
  • Modèle / numéro de série
    Lot Number 813900 (Lot number is located on packaging for individual syringes)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    ReliOn Insulin syringes - 1cc, 31 G || Distributed by: Can-Am Care, Corp., Alpharetta, GA
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Adresse du fabricant
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • 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