Events

Rappel de Truform Therapeutic Classic Medical Style Compression Stockings

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 Surgical Appliance Industries.

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
    60371
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0391-2012
  • Date de mise en oeuvre de l'événement
    2011-10-07
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105182
  • 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
    Stocking, medical support (for general medical purposes) - Product Code FQL
  • Cause
    During an audit with the fda, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). this resulted in the device history files containing s.
  • Action
    The firm, Surgical Appliance Industries sent an URGENT: MEDICAL DEVICE RECALL letters dated November 7, 2011 to all affected customers. The letter described the products, problem and actions to be taken. Customers were instructed to immediately examine their inventory and quarantine all product(s) subject to recall for return and exchange. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Recall Response Form. For any questions contact Quality Systems Manager, at 513-271-4594 ext. 282.

Device

Truform Therapeutic Classic Medical Style Compression Stockings
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Australia, Canada, Colombia, Hong Kong, Peru, Singapore, Spain, and Venezuela.
  • Description du dispositif
    Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209 || Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.
  • Manufacturer
    Surgical Appliance Industries

Manufacturer

Surgical Appliance Industries
  • Adresse du fabricant
    Surgical Appliance Industries, 3960 Rosslyn Dr, Cincinnati OH 45209
  • Société-mère du fabricant (2017)
    Surgical Appliance Industries
  • Source
    USFDA