Events

Rappel de Beacon Tip Centimeter, White Vessel, and Vessel Sizing Catheter

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 Cook 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
    74010
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2612-2016
  • Date de mise en oeuvre de l'événement
    2016-04-15
  • Date de publication de l'événement
    2016-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145893
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Cause
    Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
  • Action
    Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.

Device

Beacon Tip Centimeter, White Vessel, and Vessel Sizing Catheter
  • Modèle / numéro de série
    All Lots. Catalog prefixes NR5.0  Catalog/product number; Global/order number Centimeter Sizing: NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-70-P-10S-PIG-CSC-20 G31215 NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-100-P-10S-0-CSC-20 G31214 White Vessel Sizing: NR5.0-35-70-P-10S-PIG-WSC G31224 NR5.0-35-70-P-10S-CFP-WSC G31227 NR5.0-35-70-P-10S-0-WSC G31228 NR5.0-35-65-P-6S-VCF-WSC G31229 NR5.0-35-100-P-10S-PIG-WSC G31226 Vessel Sizing: NR5.0-35-90-P-10S-VCF-CAVA G31233 NR5.0-35-90-P-10S-PIG-CAVA G31231 NR5.0-35-70-P-10S-VCF-CAVA G31232 NR5.0-35-70-P-10S-PIG-CAVA G31230
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
  • Description du dispositif
    Beacon¿ Tip Centimeter Sizing Catheter || Beacon¿ Tip White Vessel Sizing Catheter || Beacon¿ Tip Vessel Sizing Catheter || Catheter, Intravascular, Diagnostic || The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA