Events

Rappel de Device Recall FlexiSeal Fecal Management System Advanced Odor Control 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 ConvaTec.

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
    50225
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0618-2009
  • Date de mise en oeuvre de l'événement
    2008-11-20
  • Date de publication de l'événement
    2008-12-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75003
  • 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
    Gastrointestinal Tubes and Accessories - Product Code KNT
  • Cause
    It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
  • Action
    Urgent Product Correction Letters were sent by first class mail on November 18, 2008 to Healthcare Professionals and ConvaTec Reps. The reason for the recall was identified along with possible risk to patient. Healthcare professionals were asked to use sufficient lubricating jelly during the insertion process with special care given to those who have a tendency to bleed or are on anti-coagulant medication. Physician should be notified if rectal bleeding or abdominal symptoms develop. ConvaTec reps were asked to contact all health care professionals to whom product or samples were given and reinforce the importance of proper lubrication and following the directions. A return form is to be completed by ConvaTec reps for each visit indicating the name of the Health Care Provider and that the they personally received notice of the product correction. All remaining sample products are to be returned to Besta, Franklin, WI.

Device

Device Recall FlexiSeal Fecal Management System Advanced Odor Control Kit
  • Modèle / numéro de série
    Lot number 08-TM-51
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Description du dispositif
    Flexi-Seal Fecal Management System Advanced Odor Control Kit. || Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104 || ConvaTec || Skillman, NJ || Made in USA with imported components || "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool."
  • Manufacturer
    ConvaTec

Manufacturer

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