FDAFDA · Alimentos y medicamentos·N.º oficial Z-2135-2014
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
Publicado el 20 de agosto de 2014 · Inicio del retiro: 7 de agosto 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
Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Enhancement Medical, LLC
- Distribuidor
- Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
- Lote
- Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203. RECALL EXPANDED 7-8-2014 to include ALL LOTS.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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