Events

Retiro De Equipo (Recall) de Device Recall HIgHFlo Subcutaneous Safety Needle Sets

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 Repro-Med Systems, 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
    76569
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0318-2018
  • Fecha de inicio del evento
    2016-03-10
  • Fecha de publicación del evento
    2018-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153552
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    On 2/24/2016 during post sterilization inspection of part number f180 precision flow rate tubing, lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for part number #317036 5 x 6.5 st bag combo. the firm decided to recall precision flow rate tubing and rms high-flo subcutaneous safety needles sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. the firm determined that the issue was large than just the one lot and recalled the product via march 10, 2016 voluntary medical device corrections and removal notification to customers. the recall was conducted without fda notification.
  • Acción
    On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.

Device

Device Recall HIgHFlo Subcutaneous Safety Needle Sets
  • Modelo / Serial
    Lot Numbers: 7.069/16, 7.068/16, 7.066/16, 7.065/16, 7.064/16, 7.063/16, 7.062/16, 7.061/16, 7.060/16, 7.059/16, 7.058/16, 7.057/16, 7.056/16, 7.055/16, 7.054/16, 7.053/16, 7.052/16, 7.051/16, 7.050/16, 7.049/16, 7.048/16 & 7.046/16.  Expiration: 2019-02
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide in US
  • Descripción del producto
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609, RMS22606, RMS42609 & RMS32612.
  • Manufacturer
    Repro-Med Systems, Inc.

Manufacturer

Repro-Med Systems, Inc.
  • Dirección del fabricante
    Repro-Med Systems, Inc., 24 Carpenter Rd, Chester NY 10918-1057
  • Empresa matriz del fabricante (2017)
    Repro-Med Systems Inc
  • Source
    USFDA