Events

Rappel de Merit Medical's Custom Procedural Tray

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
    63231
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0663-2013
  • Date de mise en oeuvre de l'événement
    2012-09-14
  • Date de publication de l'événement
    2013-01-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113073
  • 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
    Saline, vascular access flush - Product Code NGT
  • Cause
    Custom procedural trays/kits contain 0.9% sodium chloride injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. the particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the.
  • Action
    Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" dated September 14, 2012 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were requested to ensure that all appropriate personnel are notified of the affected Merit trays so that they can take immediate action. They were instructed to quarantine all affected kits, remove the bag of 0.9% Sodium Chloride and return the affected product to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form and immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Consignees were given product return instructions.

Device

Merit Medical's Custom Procedural Tray
  • Modèle / numéro de série
    Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in Mississippi and New Jersey.
  • Description du dispositif
    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits 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