Events

Rappel de Device Recall Clinical Innovations

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 Clinical Innovations, LLC.

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
    70137
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1014-2015
  • Date de mise en oeuvre de l'événement
    2014-12-30
  • Date de publication de l'événement
    2015-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132298
  • 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
    Intrauterine tamponade balloon - Product Code OQY
  • Cause
    Potential for a balloon leak in all lots of (cts-1000) manufactured since august 2014.
  • Action
    Clinical Innovations sent an "Urgent - Medical Device Recall" letter dated December 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They will be instructed to quarantine remaining product. A company representative will visit the hospital and retrieve the product in accordance to instructions detailed on the Representative Recall Reconciliation Instructions. The representative will reconcile the inventory on the Field Reconciliation Form and return the product to Clinical Innovations as indicated on the instructions. The address for the devices to be returned is included on the Representative Recall Reconciliation Instruct Clinical Innovations is working diligently to resolve this issue. In the meantime ,please quarantine any remaining product in your hospital. A company representative will contact you and make arrangements for the return of the product. Clinical Innovations will provide replacement product as soon as it becomes available. If you have any questions,call Clinical Innovations,at 1-(888)268-6222 or your service representative, as is the name of the Company Contact.

Device

Device Recall Clinical Innovations
  • Modèle / numéro de série
    Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
  • Description du dispositif
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
  • Manufacturer
    Clinical Innovations, LLC

Manufacturer

Clinical Innovations, LLC
  • Adresse du fabricant
    Clinical Innovations, LLC, 747 W 4170 S, Murray UT 84123-1364
  • Société-mère du fabricant (2017)
    Eqt Partners Ag
  • Source
    USFDA