PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 27, 2015 Initiated: February 26, 2015 #Z-1641-2015

Product Description

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.

Reason for Recall

During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

Details

Recalling Firm
Ethicon Endo-Surgery Inc
Units Affected
6,744 devices
Distribution
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.
Location
Blue Ash, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ethicon Endo-Surgery Inc. Units affected: 6,744 devices.
Why was this product recalled?
During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1641-2015.