Events

Rappel de Convatec Inc.

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 Convatec 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
    68292
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1785-2014
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • Date de publication de l'événement
    2014-06-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127287
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Cause
    Convatec inc. is recalling flexi-seal fms control kit since it does not have a 510k. in addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control is not meeting expectations or those of customers. specifically, the auto-valve feature that is unique to the flexi-seal control has not been consistently performing relative.
  • Action
    Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014.

Device

Convatec Inc.
  • Modèle / numéro de série
    13-FM-0301  13-FM-0302  13FM0303  13-FM-0303  13FM0309  13VM509948  13VM509949  13VM510046  13VM512473  13VM513636  13VM513642  13VM516733  13VM520039  13VM521731  13VM521733  13VM524363  13VM524364  13VM527149  13VM527150  13VM528992  13VM528994  13VM531214  14FM0301  14VM531935  14VM532098
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    Convatec Flexi Seal Control Fecal Management System Rx Only || REF 411107 || Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
  • Manufacturer
    Convatec Inc.

Manufacturer

Convatec Inc.
  • Adresse du fabricant
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA