FDAFDA · Alimentos y medicamentos·N.º oficial Z-0665-2015
PKG, CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080174. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Publicado el 24 de diciembre de 2014 · Inicio del retiro: 17 de noviembre de 2014
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 parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Endoscopy
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Lote
- 34084 36925 38749 38885 38955 39654 44365 44521 44924 44925 45030 45806 46020 46328 46472 47128 47157 47614 47955 48064 48403 48404 48645 48699 48768 49015 49479 49832 50044 50237 50859 51025 51179 51390 51612 51910 52116 52651 52998 53778 57318 57476 58259 59578 59722 59739 61128 62393 63206 63761 64136 65374 65921 67020 68011 68985 70523 74752 75614 75641 76643 76818 76961 78384 79424 80272 81574 83533 85051 85137 85913 86043 86264 86431 89121
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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