FDA-Device2015-05-27Class II
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Ethicon Endo-Surgery Inc
Hazard
During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
Sold states
Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
Affected count
6,744 devices
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2015Don't want to check this manually?
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