Events

Rappel de Device Recall Cordis Radial Source Spring Wire Transradial Access Kit Product

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 Greatbatch Medical.

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
    65464
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1608-2013
  • Date de mise en oeuvre de l'événement
    2013-05-31
  • Date de publication de l'événement
    2013-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118983
  • 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
    Cordis corporation, inc and greatbatch medical are recalling one lot of the cordis radialsource spring wire transradial access kit product. some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
  • Action
    Greatbatch Medical and Cordis sent an "Urgent Field Safety Notice" dated May 31, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were instructed: 1.Read the Description of the problem section. 2. Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. 3. Review, complete, sign and return the enclosed Acknowledgement Form in accordance with the directions on the form. 4. Either return any affected product per the attached instruction, or contact your local sales representative to facilitate return of the affected product. Credit will be provided. 5. Pass on this notice to anyone in your facility that needs to be informed. 6. If any product listed above has been forwarded to another facility, contact that facility to arrange return. 7. Maintain awareness of this notice until all product listed above has been removed from the facility and returned to Cordis. 8. Maintain a copy of this notice with affected product until product is returned. We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Cordis and Greatbatch are committed to maintaining your confidence in the safety and quality of the products that Greatbatch manufactures and Cordis supplies. Further questions please call (763) 951-8181.

Device

Device Recall Cordis Radial Source Spring Wire Transradial Access Kit Product
  • Modèle / numéro de série
    Manufacturing Lot : W18499722
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.
  • Description du dispositif
    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. || Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Adresse du fabricant
    Greatbatch Medical, 2300 Berkshire Ln N, Minneapolis MN 55441-4575
  • Société-mère du fabricant (2017)
    Integer Holdings Corporation
  • Source
    USFDA