Events

Rappel de Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheters

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
    75409
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0380-2017
  • Date de mise en oeuvre de l'événement
    2016-10-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150221
  • 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
    The ep catheters may be mislabeled for french size during reprocessing.
  • Action
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, 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 you have any questions, contact Senior Director RA at 1(888)888-3433.

Device

Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheters
  • Modèle / numéro de série
    Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following; AZ, MN and MO.
  • Description du dispositif
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters || Model Numbers: || 401940, 402004 || UPC Code: || 00885825007409 || 00885825007744 || Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. || Reprocessed Diagnostic EP Catheters are 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