Events

Retiro De Equipo (Recall) de Device Recall Peripherally Inserted Central Catheters (PICC)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Angiodynamics Inc. (Navilyst Medical Inc.).

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    75322
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0708-2017
  • Fecha de inicio del evento
    2016-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150100
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Causa
    Medline industries, inc. supplies navilyst with sterile package gloves included in the tandem packing of the maximal barrier nursing kits. medline has determined that specific lots of the gloves supplied to navilyst contain an incorrect expiration date. navilyst has confirmed that medlines affected sterile gloves (medline part number msg1075/msg3075) have been included in a limited number of kits.
  • Acción
    Navilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an incorrect expiration date. Actions to be taken: - Customers should immediately remove the affected product from 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 customers may have further distributed affected product. Customers should also promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) via email to recall@angiodynamics.com. Customers with questions can call 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time). For questions regarding this recall 518-792-4112.

Device

Device Recall Peripherally Inserted Central Catheters (PICC)
  • Modelo / Serial
    Batch/Lot: 505722, 5056512
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.
  • Descripción del producto
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is 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 and nutrients; the sampling of blood; and for power injection of contrast media
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • Dirección del fabricante
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA