FDAFDA · Alimentos y medicamentos·N.º oficial Z-0804-2013
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
Publicado el 20 de febrero de 2013 · Inicio del retiro: 14 de enero de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Breg Inc
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
- Lote
- Affected product will be identified by date of manufacture from January 2010 through October 2012
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States