Events

Rappel de Device Recall Epicor LP Connecting Cable, CC6LPCE

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 St. Jude Medical 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
    50521
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0946-2009
  • Date de mise en oeuvre de l'événement
    2008-12-09
  • Date de publication de l'événement
    2009-01-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75694
  • 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
    Electrosurgical cutting and coagulation device - Product Code OCL
  • Cause
    Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the ablation control system unit.
  • Action
    The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.

Device

Device Recall Epicor LP Connecting Cable, CC6LPCE
  • Modèle / numéro de série
    All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412.  ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.
  • Description du dispositif
    Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA || Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
  • Manufacturer
    St. Jude Medical Inc

Manufacturer

St. Jude Medical Inc
  • Adresse du fabricant
    St. Jude Medical Inc, 240 Santa Ana Ct, Sunnyvale CA 94085-4512
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA