Events

Rappel de Spirotome

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 Medical 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
    69417
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0124-2015
  • Date de publication de l'événement
    2014-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130489
  • 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
    Instrument, biopsy - Product Code KNW
  • Cause
    Medinvents, the manufacturer of the spirotome" soft-tissue biopsy needle set distributed by cook medical, has initiated a voluntary recall of these products. the recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
  • Action
    On 9/26/2014, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and institutions Risk Managers/Recall Administration with instructions for returning the affected product. 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. For questions, call Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Device

Spirotome
  • Modèle / numéro de série
    Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10;  SS-10-15; SS-14-06; SS-14-10; SS-14-15.   Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.
  • Description du dispositif
    Spirotome" Soft-Tissue Biopsy Needle Set. || The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
  • Manufacturer
    Cook Medical Incorporated

Manufacturer

Cook Medical Incorporated
  • Adresse du fabricant
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA