Events

Rappel de Device Recall Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set

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 Angiodynamics, 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
    49042
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2397-2008
  • Date de mise en oeuvre de l'événement
    2008-07-07
  • Date de publication de l'événement
    2008-09-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72578
  • 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
    Implanted Hemodialysis Catheter - Product Code MSD
  • Cause
    The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
  • Action
    AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to AngioDynamics. 3. Ship the recalled product(s) to AngioDynamics. Consignees will be credited for the returned products. Credits will only be issued for returned product that is within the scope of the recall. Reference Return Authorization Number ___ on the outside of the shipping box and include a copy of the Centros Recall Reply Form with the return shipment. --- The letters also provide actions to be taken for product(s) in use: ANGIODYNAMICS recommends that physicians continue to follow facility protocols for inserting dialysis catheters and monitoring dialysis catheter patients. It is recommended that physicians consider evaluation of patients with an indwelling Centros catheter to assure the catheter is properly secured. As stated in the product's instructions for use, it is recommended that the catheter be secured/sutured for the entire duration of implantation. If the sutures have been cut, consider re-suturing to maintain proper catheter position. Do not rely on ingrowth of the cuff to maintain proper catheter position. This failure does not affect the function or integrity of the catheter itself and there have no reports of patient injury due to this problem. For questions, concerns, or more detailed instructions on how to

Device

Device Recall Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set
  • Modèle / numéro de série
    Lots S08B02, S08B06, S08C01, S08D02, and S08D11
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY USA 12804.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Adresse du fabricant
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12801
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA