FDAFDA · Alimentos y medicamentos·N.º oficial Z-1772-2013
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
Publicado el 31 de julio de 2013 · Inicio del retiro: 8 de abril 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
The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ethicon Endo-Surgery Inc
- Distribuidor
- Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.
- Lote
- Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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