FDAFDA · Alimentos y medicamentos·N.º oficial Z-0355-2014
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): 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-45547
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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