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U.S. Department of Health and Human Services

Class 2 Device Recall Endo GIA Auto Suture Universal Articulating Loading

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  Class 2 Device Recall Endo GIA Auto Suture Universal Articulating Loading see related information
Date Initiated by Firm August 12, 2020
Create Date October 01, 2020
Recall Status1 Open3, Classified
Recall Number Z-0004-2021
Recall Event ID 86214
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Code Information Lot Numbers:  T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall		 The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Recalled Product Return Form even if you do not have inventory. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 900,007 total
Distribution Worldwide distribution - US Nationwide and Global Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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