Events

Rappel de Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing 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 Angiodynamics Inc. (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
    74948
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0714-2017
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148877
  • 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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Cause
    There is a potential for stylet stiffening that is not accurately represented on the labeling. the label states that product includes a stylet with an outside diameter (od) measuring 0.014, however, the product may contain a stylet with an outside diameter (od) measuring 0.016.
  • Action
    Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for your returned product. Promptly complete, sign and return the Reply Verification Tracking Form by email to recall@angiodynamics.com or by Fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.

Device

Device Recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit
  • Modèle / numéro de série
    Lot #: 4941411
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
  • Description du dispositif
    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • Adresse du fabricant
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA