Device product
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Z-2326-2021
Product summary
- Event
- Event 88349
- Status
- Terminated
- Classification
- Class II
- Quantity
- 763 eaches
- Official record key
device-enforcement:Z-2326-2021
Official wording
Reason: Mislabeled: Labeled on the package as 60mm contains 45mm devices
Code information: Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.
Derived failure modes
-
Labeling or packaging
Mislabeled