Events

Rappel de Crossover Reinforced Catheter Introducer System

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 Thomas Medical Products 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
    53672
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0120-2010
  • Date de mise en oeuvre de l'événement
    2009-10-21
  • Date de publication de l'événement
    2009-11-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86296
  • 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
    Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
  • Action
    An "Urgent Medical Device Correction" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc. Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30AM to 5:OOPM Eastern Standard Time, for questions about product return.

Device

Crossover Reinforced Catheter Introducer System
  • Modèle / numéro de série
    Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States (FL and MN).
  • Description du dispositif
    Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Adresse du fabricant
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA