Events

Rappel de Device Recall Custom Procedural Trays

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
    64078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1660-2013
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • Date de publication de l'événement
    2013-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115330
  • 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
    General surgery tray (kit) - Product Code LRO
  • Cause
    Custom procedural trays contain medrad hand controller sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
  • Action
    Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" letter dated November 21, 2012, to affected customer. The letter identified the product, the problem, and the action to be taken by the customer: Ensure all personnel within their institution to which the affected Merit trays were distributed are notified, quarantine all affected trays and return the affected product to Merit - Maastricht. Complete and sign the Customer Response Form attached to this letter and perform the following steps:(1) Immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031. (2) Mail the completed original Customer Response Form from (1) above using the provided postage-paid, self-addressed envelope to Merit. Product Return Instructions: Please return the affected products by shipping them back to Merit via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department, RGA #NC-54948 Merit Medical Maastricht, Amerikalaan 42, 6199 AE Maastricht - Airport, The Netherlands. NOTE: A copy of the Customer Response Form must accompany the shipment. If you have any questions, please call 1-804-416-1048.

Device

Device Recall Custom Procedural Trays
  • Modèle / numéro de série
    Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Military Hospital on base in Landstuhl, Germany
  • Description du dispositif
    Custom Procedural Trays: Merit's Custom Angio Kits || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Adresse du fabricant
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Société-mère du fabricant (2017)
    Merit Medical Systems Inc
  • Source
    USFDA