ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments h
Summary
The FDA issued a Class II for ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or cr by Ethicon Endo-Surgery Inc. Reason: Mislabeled: Labeled on the package as 60mm contains 45mm devices.
Details
Source
Device Recall
External ID
Z-2326-2021
Action Date
2021-08-25
Status
Terminated
Category
device
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
Lot/Code Info: Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
Quantity Affected: 763 eaches
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-03
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon Endo-Surgery Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Endo-Surgery Inc have FDA actions?
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2326-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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