Events

Retiro De Equipo (Recall) de Device Recall HEPARIN LOCK FLUSH SOLUTION

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 App Pharmaceuticals 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
    57878
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1825-2012
  • Fecha de inicio del evento
    2010-05-20
  • Fecha de publicación del evento
    2012-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109646
  • 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, vascular access flush - Product Code NZW
  • Causa
    Cgmp deviations: incomplete documentation associated with test results.
  • Acción
    APP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.

Device

Device Recall HEPARIN LOCK FLUSH SOLUTION
  • Modelo / Serial
    Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution and Puerto Rico
  • Descripción del producto
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only || To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
  • Manufacturer
    App Pharmaceuticals Llc

Manufacturer

App Pharmaceuticals Llc
  • Dirección del fabricante
    App Pharmaceuticals Llc, 1501 E Woodfield Rd, Suite 300 East, Schaumburg IL 60173-6052
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA