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
Check against the official notice below — it lists the full affected range.
Ethicon Endo-Surgery Inc. is recalling 763 ECHELON FLEX Powered Plus Staplers due to mislabeling. The devices are labeled on the package as 60mm but actually contain 45mm devices. The affected lot is U94V47 with an expiration date of July 31, 2023. These surgical instruments are used for transection, resection, and creation of anastomoses in open or minimally invasive procedures and were distributed worldwide, including in the United States (specifically Maryland and Washington), Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, and the United Kingdom.
The recall record does not specify what action affected consumers should take regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Reason for recall: Mislabeled: Labeled on the package as 60mm contains 45mm devices Distribution: 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. Quantity: 763 eaches Lot/code info: Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.