Events

Rappel de Device Recall ReSolve Locking Drainage Catheters

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
    71694
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2352-2015
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • Date de publication de l'événement
    2015-08-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138760
  • 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 irrigation - Product Code GBQ
  • Cause
    Merit medical systems, inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the merit resolve drainage catheters and the actual device in the package.
  • Action
    Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions required of you: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Please work with your Merit Sales Representative to arrange product return. 4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365.

Device

Device Recall ReSolve Locking Drainage Catheters
  • Modèle / numéro de série
    Lot No: E796578 E796579  MR792035 MR786325  MR797946  MR791206  MR791212 MR786923  E796605 MR786311  MR791660 E796647 RL MR795466  MR786301  E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318  MR786319
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the Virgin Islands.
  • Description du dispositif
    ReSolve Locking Drainage Catheters || The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
  • 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