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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0663-2015

PKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. 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
197 38410 38539 39800 43905 44707 45337 45663 46563 47266 47477 47499 47500 47957 48256 48346 48694 49042 49141 50045 51396 51915 53499 54427 57166 57384 57979 58704 59130 59453 60572 61045 62137 63233 64030 64480 66874 67351 67645 67981 69931 73431 75611 75612 76147 76197 76198 79810 80433 83797 84016 84191 85143 85382
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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