Events

Rappel de Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating

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 Vance Products Incorporated.

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
    50223
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0980-2009
  • Date de mise en oeuvre de l'événement
    2008-11-10
  • Date de publication de l'événement
    2009-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-11-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75002
  • 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
    Stent, ureteral - Product Code FAD
  • Cause
    "soft" stents were placed in "firm" stent outer boxes. the soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
  • Action
    Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.

Device

Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating
  • Modèle / numéro de série
    Lot Number: U1753668.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • Description du dispositif
    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.
  • Manufacturer
    Vance Products Incorporated

Manufacturer

Vance Products Incorporated
  • Adresse du fabricant
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA