Events

Rappel de Device Recall Electrophysiology catheter cables

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 Sterilmed 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
    77190
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2669-2017
  • Date de mise en oeuvre de l'événement
    2017-05-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155303
  • 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
    unknown device name - Product Code N/A
  • Cause
    Sterilmed is recalling all lots of specific product codes of unexpired sterilmed reprocessed ep ablation cables because sterilmed determined that the cables are class iii devices and thus require, but do not currently have, premarket review and approval.
  • Action
    Sterilmed sent an Urgent Notice Medical Device Recall letter dated April 25, 2017, to all affected customers. The letter identified affected product, stated reason for recall. Affected devices were asked to be quarantined, until returned to Stericycle, by August 31, 2017 to qualify for credit. A response form was asked to be returned. Questions can be directed to Sterilmed's Customer Care Team at 1-888-541-0078. For further questions, please call ( 877 ) 787-0369.

Device

Device Recall Electrophysiology catheter cables
  • Modèle / numéro de série
    all lots
  • Distribution
    US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
  • Description du dispositif
    Electrophysiology catheter cables are designed || as electrode cables with a multi-pin connector on || the distal end and the appropriate number of tails || on the proximal end. The cables serve two || different purposes. They either serve as an || extension between an EP catheter and equipment || out of reach or they interface an EP catheter with || the appropriate external stimulation of recording || equipment.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Adresse du fabricant
    Sterilmed Inc, 5010 Cheshire Pkwy N Ste 2, Minneapolis MN 55446-4101
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA