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Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Recalled November 6, 2019 · FDA recall Z-0203-2020 · Ethicon Endo-Surgery
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. · FDA Class I
Units
2112 units
Sold at
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Description
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.
Product
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Manufacturer(s)
Ethicon Endo-Surgery Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →