Events

Rappel de Device Recall Merit RAD BOARD

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 Merit Medical Systems, Inc..

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
    67206
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0901-2014
  • Date de mise en oeuvre de l'événement
    2013-12-18
  • Date de publication de l'événement
    2014-01-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124977
  • 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
    Table and attachments, operating-room - Product Code BWN
  • Cause
    Merit medical systems, inc. is voluntarily recalling one lot (b507171) of rad board rb 100 devices. the affected devices are missing the main label which graphically depicts patient orientation on the board. the issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded xenolite) could obscure patient anatomy during fluoroscopy. there.
  • Action
    Merit Medical Systems, Inc.sent a letter voluntarily recalling one lot (B507171) of RAD BOARD" RB100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs. Merit requests that customers stop using these devices immediately until the product has been replaced by their Merit sales representative. Customers with questions were instructed to call 1-801-208-4344 or 1-801-208-4365. For questions regarding this recall call 801-208-4301.

Device

Device Recall Merit RAD BOARD
  • Modèle / numéro de série
    lot B507171
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
  • Description du dispositif
    Radial Assist RAD BOARD, used to support the || weight of a patient's arm and supplies for a medical procedure. || The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Adresse du fabricant
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Société-mère du fabricant (2017)
    Merit Medical Systems Inc
  • Source
    USFDA