Events

Rappel de Device Recall Benephit

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 Angiodynamics Worldwide Headquarters.

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
    60587
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0509-2012
  • Date de mise en oeuvre de l'événement
    2011-12-05
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105887
  • 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
    Catheter, continuous flush - Product Code KRA
  • Cause
    The benephit xt infusion system may contain hairline cracks in the sheath hub.
  • Action
    Angiodynamics Worldwide Headquarters sent a Urgent Medical Device Recall Letter and Response Forms dated December 2, 2011, to all affected customers via Certified Mail on December 5, 2011. The recall is being extended to the medical user level. Customers will be instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. A Return Authorization number (RA #) will be assigned to each customer in the recall notification letter and a UPS account will be provided for return freight. A reply form was provided with the recall notification letter to be completed by each consignee. ACTIONS TO BE TAKEN BY CUSTOMER / USER: (1.) Identify and segregate the recalled lots that are in your possession. (2.) Complete the enclosed Benephit XT Infusion System Recall Reply Form and fax it to the attention of the Benephit XT Infusion System Recall Coordinator at 518-798-1360. The form lists the catalog number, lot numbers, and quantity our records indicate your facility has received. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number on the outside of the shipping box and include a copy of the Benephit Infusion System Recall Reply Form with your shipment. (4.) If you have distributed the affected product/lot, please inform your customers of this recall action immediately, and have them return the recalled units to you. --- Certified Mail will verify delivery to each domestic consignee. Non-respondents will be contacted by telephone or via e-mail. --- Corrective Action: Returned product will be quarantined and final disposition has not been determined at this time. A corrective action has been initiated by AngioDynam

Device

Device Recall Benephit
  • Modèle / numéro de série
    Lot C23415
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of New York, Pennsylvania, Virginia, Kentucky, Iowa, Illinois, Missouri, Louisiana, Texas, and Utah.
  • Description du dispositif
    Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 || Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Adresse du fabricant
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA