The Implant Files -
International Medical Devices Database
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Retiro De Equipo (Recall) de G.O.L.F.F. - (ANTI-FOG SOLUTION FOR ENDOSCOPES)
Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BATRIK MEDICAL MANUFACTURING 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
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ID del evento
45980
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Clase de Riesgo del Evento
II
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Fecha de inicio del evento
2014-10-03
- País del evento
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Fuente del evento
HC
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Notas / Alertas
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada. -
Notas adicionales en la data
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Causa
As a result of an investigation following a customer complaint for the the golff-ro (g.O.L.F.F.-anti-fog solution) lot no. 49691 we have uncovered that the labels on the sterile pouches may have an expiry date error of 2018-14. the outer boxes have the correct expire date: 2018-04 however some pouches within these boxes have been labeled correctly with the correct expire date being: 2018-04 and some have been labeled incorrectly with the incorrect expiry date being 2018-14.
Device
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Modelo / Serial
Model Catalog: G.O.L.F.F. (Lot serial: 49691)
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Descripción del producto
G.O.L.F.F.-(ANTI-FOG SOLUTION FOR ENDOSCOPES)
- Manufacturer
Manufacturer
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Dirección del fabricante
DORVAL
- Empresa matriz del fabricante (2017)
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Source
HC