Events

Rappel de Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning 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 Covidien LLC.

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
    68243
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1997-2014
  • Date de mise en oeuvre de l'événement
    2014-05-08
  • Date de publication de l'événement
    2014-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127205
  • 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
    Support, patient position - Product Code CCX
  • Cause
    Straps may separate from the foam pad.
  • Action
    Covidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.

Device

Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit
  • Modèle / numéro de série
    14085, 14086, 14092, 14095, 14101, 14106  *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
  • Description du dispositif
    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 || Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Adresse du fabricant
    Covidien LLC, 15 Hampshire Street, 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