Events

Rappel de Professional Hospital Supply,

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
    75302
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0366-2017
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150071
  • 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
    General surgery tray - Product Code LRO
  • Cause
    Added instructions for use: after application, inspect the light glove for barrier integrity.
  • Action
    Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888

Device

Professional Hospital Supply,
  • Modèle / numéro de série
    All lot codes in the following:  Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
  • Description du dispositif
    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove || Item Number Description || 380789003 SURE SET SINGLE BASIN PACK || 400383006 MAJOR BASIN PACK || 400383007 MAJOR BASIN PACK || 618275004 BASIN PACK || Product Usage: || A disposable, sterile, single-use cover for compatible surgical light handles
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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