ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Reported: November 6, 2019 Initiated: October 3, 2019 #Z-0203-2020
Product Description
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Reason for Recall
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.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 2112 units
- Distribution
- Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A. Recalled by Ethicon Endo-Surgery Inc. Units affected: 2112 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Critical. Recall number: Z-0203-2020.
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