Events

Rappel de Device Recall NAMIC (TM) Convenience Kit

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 Navilyst Medical, 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
    70322
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1188-2015
  • Date de mise en oeuvre de l'événement
    2015-01-09
  • Date de publication de l'événement
    2015-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133748
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Cause
    The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. use of a fluid management convenience kit, where sterility has been breached, may result in an increased risk of infection.
  • Action
    Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.

Device

Device Recall NAMIC (TM) Convenience Kit
  • Modèle / numéro de série
    Lots 4692107 and 4757752
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
  • Description du dispositif
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. || NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Adresse du fabricant
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Société-mère du fabricant (2017)
    Navilyst Medical, Inc
  • Source
    USFDA