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
    62749
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0464-2013
  • Date de mise en oeuvre de l'événement
    2012-06-08
  • Date de publication de l'événement
    2012-12-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111628
  • 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 stryker hytrel togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
  • Action
    The firm, Merit Medical, sent an "URGENT PRODUCT RECALL NOTICE" letter dated June 8, 2012 to its customers by letter sent by US Postal Service - Certified Mail Receipt describing the problem, instructions as to actions that need to be taken, and requesting the customer to complete and sign the Customer Response Form and immediately fax a copy to this form to 1-804-416-1031. Customers were instructed to mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Should the customer choose to return the product for rework, they are to return the affected products by shipping them back to Merit Medical Systems via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department RGA #NC-53417, Merit Medical Systems, Inc., Attn: Manager of Quality Assurance and Regulatory Affairs, 12701 Kingston Ave., Chester, VA 23836. For questions customers were instructed to contact Manager of Quality Assurance and Regulatory Affairs at 1-804-416-1048 or email: jbraxton@merit.com.

Device

Device Recall Custom Procedural Trays
  • Modèle / numéro de série
    Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: US including states of: NE and SD.
  • Description du dispositif
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 || 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.
  • 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