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Recall Observatory FDA recall evidence

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

June 03, 2021

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
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

    reason.labeling_packaging · v1.0.0

    Mislabeled