Events

Rappel de Device Recall iCAST and Advanta

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 Atrium Medical Corporation.

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
    77342
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2761-2017
  • Date de mise en oeuvre de l'événement
    2017-05-25
  • Date de publication de l'événement
    2017-07-07
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155797
  • 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
    Prosthesis, tracheal, expandable - Product Code JCT
  • Cause
    Firm received a complaint that a customer who ordered an advanta v12 7mm x 22mm x 120cm received an advanta v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. the complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). the complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. this was the only complaint received for this non-conformance.
  • Action
    The firm, Getinge/Maquet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2017 via FedEx overnight to affected US consignees via FedEx Next Day Air. Getinge sent a second "URGENT MEDICAL DEVICE RECALL LETTER" dated June 2, 2017 via FedEx overnight to the affected customers in order to correct a product code/part number due to a typo in the initial letter and to assist in identifying the labeling problem. The letters described the product, problem and actions to be taken. Customers are instructed to examine your inventory; remove affected products; quarantine and place in a secure location; if you have the affected product, contact Getinge Customer Service at 1-603-880-1433, Monday through Friday between 9:00 am to 5:00 pm for RA and shipping instructions to return affected product to the Manufacturer, and complete and Return the enclosed Medical Device - Recall Response Form to email: catheterhub.us@getinge.com or fax to 1-973-807-9207. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.

Device

Device Recall iCAST and Advanta
  • Modèle / numéro de série
    Part Number 85455: Lots 240735, 240523;  Part Number 85355: Lot 240734
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
  • Description du dispositif
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) || Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) || The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Adresse du fabricant
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA