FDA-Device2019-11-06Class I
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Ethicon Endo-Surgery Inc
Hazard
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Sold states
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Affected count
255 units
Manufactured in
4545 Creek Rd, Blue Ash, OH, United States
Products
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2020Don't want to check this manually?
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