FDAFDA · Alimentos y medicamentos·N.º oficial Z-2953-2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
Publicado el 23 de septiembre de 2020 · Inicio del retiro: 4 de agosto de 2020
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
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Integra LifeSciences Corp.
- Distribuidor
- Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
- Lote
- Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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