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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0671-2015

PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. 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
43974 140264 741253 847523 847524 943732 944097 945981 1041995 1042254 1042638 1042639 1042648 1141194 1141612 1141659 1144489 1144665 1144937 1144991 1145683 1145974 1146367 1146539 1147039 1240416 1241941 1244276 1244531 1341466 1341558 1343293 1343703 1440404 1440683
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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