Events

Rappel de Device Recall Urological catheter

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 Apogee Medical, Inc.

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
    49027
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2394-2008
  • Date de mise en oeuvre de l'événement
    2008-07-17
  • Date de publication de l'événement
    2008-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72548
  • 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
    Catheter, urethral - Product Code GBM
  • Cause
    Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. also the sterility of the product could be compromised.
  • Action
    Distributors and Retailers that have received any of the Catalog Numbers listed in the letter titled URGENT MEDICAL DEVICE RECALL were notified on/about July 17, 2008. Recipients of the letter are being requested to review their inventory and return any of the applicable Catalog Items from the specific lot numbers listed in the recall letter. Distributors are being instructed to notify their customers and inform them of the recall with a copy of the recall letter. Their notification should instruct their customers to return the recalled product to them so that they could return the product to Apogee Medical LLC. In addition to the initial letter, follow-up letters, telephone calls and emails will be utilized to assess the effectiveness of the recall. A spreadsheet has been set up and will be maintained in order to easily identify the customers that have been contacted, those who have responded and those who have returned product. If you have questions, contact Diane Peper at 919-435-5409.

Device

Device Recall Urological catheter
  • Modèle / numéro de série
    Lot number 7201
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide and Canada
  • Description du dispositif
    Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
  • Manufacturer
    Apogee Medical, Inc

Manufacturer

Apogee Medical, Inc
  • Adresse du fabricant
    Apogee Medical, Inc, 90 Weathers St., Youngsville NC 27596-7801
  • Source
    USFDA