Events

Retiro De Equipo (Recall) de Device Recall Heparin I.V. Flush Syringe 10 units/mL

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 Medefil Incorporated.

¿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
    47378
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1544-2008
  • Fecha de inicio del evento
    2008-03-20
  • Fecha de publicación del evento
    2008-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69522
  • 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
    Heparin Access Flush - Product Code NZW
  • Causa
    The heparin lock flush solution was manufactured from contaminated heparin sodium usp active pharmaceutical ingredient (api). the fda has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin api containing this contaminant.
  • Acción
    Medefil telephoned the direct accounts on 3/20/08, e-mailed them a copy of the 3/20/08 recall letter on 3/21/08, and sent the accounts a hard copy of the recall letter on 3/24/08. The accounts were informed of Medefil's recall of 19 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0773, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant in the recalled lot of API. The accounts were instructed to stop use of the 19 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact all customers to whom they further distributed the product, telling them to stop use of the product and return the product to Medefil through their supplier. The accounts were requested to complete and return to Medefil via fax the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.

Device

Device Recall Heparin I.V. Flush Syringe 10 units/mL
  • Modelo / Serial
    catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09;  catalog #MIH-2233: lot H08124, exp. date 01/10
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • Descripción del producto
    Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 || The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: || a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe || b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe
  • Manufacturer
    Medefil Incorporated

Manufacturer

Medefil Incorporated
  • Dirección del fabricante
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • Empresa matriz del fabricante (2017)
    Medefil Inc.
  • Source
    USFDA