Events

Rappel de Stryker Sustainability Solutions

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 Stryker Sustainability Solutions.

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
    73983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1708-2016
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145823
  • 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, recording, electrode, reprocessed - Product Code NLH
  • Cause
    Mislabeled for size.
  • Action
    The firm sent out customer notification letters on 04/28/16. Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed. Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found. Please return the completed and signed Recall Effectiveness Check Form to your local Stryker Sustainability Sales Representative or email to SSSPFA@stryker.com or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. On 05/12/16 the firm sent out a clarification letter to emphasize that use of affected lots of product should be discontinued. In addition, SSS would like to note that, use of devices larger than expected may result in excess force applied to the blood vessel. The risk to the patient can vary from a prolongation in procedure time, vessel rupture, organ damage or other unforeseen consequences. Some of these injuries may require surgery or other procedures to remedy. Any questions contact the Stryker Sustainability Solutions Sales Representative or Regulatory Affairs.

Device

Stryker Sustainability Solutions
  • Modèle / numéro de série
    Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017  Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the state of NY and the country of Canada.
  • Description du dispositif
    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Adresse du fabricant
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA