Events

Rappel de NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.

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 Boston Scientific Corp.

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
    32288
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1393-05
  • Date de mise en oeuvre de l'événement
    2004-05-05
  • Date de publication de l'événement
    2005-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-08-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39523
  • 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
    Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
  • Cause
    Molded handles used in angiographic manifolds may be occluded.
  • Action
    Letters dated 5/4/2004 to Risk Managers with instructions to return product.

Device

NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of S...
  • Modèle / numéro de série
    (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
  • Description du dispositif
    NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Adresse du fabricant
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA