Z-2326-2021 Class II Terminated
FDA device recall Z-2326-2021 was initiated by Ethicon Endo-Surgery Inc on June 3, 2021 and is designated Class II. Reason for recall: Mislabeled: Labeled on the package as 60mm contains 45mm devices The recall status is terminated (terminated September 14, 2022). Affected quantity: 763 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- June 3, 2021
- Termination Date
- September 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 763 eaches
Product Description
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
Reason for Recall
Mislabeled: Labeled on the package as 60mm contains 45mm devices
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.
Code Information
Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607