FDAFDA · Alimentos y medicamentos·N.º oficial Z-0356-2014
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
Publicado el 27 de noviembre de 2013 · Inicio del retiro: 13 de octubre 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
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Restoration Robotics
- Distribuidor
- Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
- Lote
- Model number FP-45399
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.