Events

Retiro De Equipo (Recall) de Device Recall WOLFPAK, Medpro, Vipat

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 First Medical Source LLC.

¿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
    60030
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0161-2013
  • Fecha de inicio del evento
    2011-07-09
  • Fecha de publicación del evento
    2012-10-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104881
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Causa
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being reclassified by the agency as a class i. the recall was initiated because first medical source has confirmed that these lots may have a higher flow rate than specified. the use of this product may lead to over-administration of drug solutions to the patients. the pr.
  • Acción
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. First Medical Source received an email from Medpro International with the following lnstruction to Customer - Informed customers to remove product from sales/discontinue use, cease distribution, remove the products from inventory and quarantine, inform their customers to retum the unused products to them, and destroy the product. Distributors' customer service will contact the customer to coordinate the return of the goods in question where required. First Medical Source emailed to their customer, Williams Medical Technologies, to informed them of the recall of the Medpro Elastomeric infusion pumps. Customer was instructed to inform them of the date and method of disposal of recalled products.

Device

Device Recall WOLFPAK, Medpro, Vipat
  • Modelo / Serial
    AccuFlux, Lot#: 91209.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the state of IL
  • Descripción del producto
    Medpro Elastomeric Infusion Pump. || AccuFlux, Model # CT-0020-100H. || Product Usage: || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
  • Manufacturer
    First Medical Source LLC

Manufacturer

First Medical Source LLC
  • Dirección del fabricante
    First Medical Source LLC, 28581 Springfield Dr, Laguna Beach CA 92677-1424
  • Empresa matriz del fabricante (2017)
    First Medical Source Llc
  • Source
    USFDA