Events

Retiro De Equipo (Recall) de Device Recall STERIDYNE STERILE PRESERVED SALINE 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 K C Pharmaceuticals 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
    54656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1223-2010
  • Fecha de inicio del evento
    2010-02-03
  • Fecha de publicación del evento
    2010-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88910
  • 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
    Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
  • Causa
    The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
  • Acción
    An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.

Device

Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION
  • Modelo / Serial
    Lot #9D524.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297. || This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
  • Manufacturer
    K C Pharmaceuticals Inc

Manufacturer

K C Pharmaceuticals Inc
  • Dirección del fabricante
    K C Pharmaceuticals Inc, 3201 Producer Way, Pomona CA 91768-3916
  • Empresa matriz del fabricante (2017)
    Kc Pharmaceuticals Inc.
  • Source
    USFDA