Events

Rappel de Device Recall PINNACLE Introducer Sheath

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 Terumo Medical Corporation.

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
    73833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2738-2016
  • Date de mise en oeuvre de l'événement
    2016-03-16
  • Date de publication de l'événement
    2016-09-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145071
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Terumo medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. if affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
  • Action
    Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.

Device

Device Recall PINNACLE Introducer Sheath
  • Modèle / numéro de série
    Please see Attachment 3
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    PINNACLE¿ Introducer Sheath || PINNACLE PRECISION ACCESS SYSTEM¿ Sheath || PINNACLE¿ TIF TIP" Introducer Sheath || PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Adresse du fabricant
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA