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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-0008-2021
Recall Event ID 86214
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - 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:  T0A013X  T7L050X  T8E048X  T8K051X  T9F118X T0A051X  T7L051X  T8E055X  T8K093X  T9G028X T0A085X  T7L052X  T8E056X  T8L129X  T9G030X T0B025X  T7M021X  T8E061X  T8L130X  T9G038X T0B032X  T7M022X  T8E062X  T8M009X  T9G088X T0B046X  T8A001X  T8E067X  T8M011X  T9G089X T0B047X  T8A002X  T8E068X  T8M097X  T9G090X T0B056X  T8A003X  T8F001X  T9A009X  T9G094X T0B073X  T8A004X  T8F002X  T9A031X  T9G159X T0B081X  T8A045X  T8F026X  T9A056X  T9G160X T0C043X  T8A046X  T8F045X  T9A099X  T9H042X T0C068X  T8A060X  T8F046X  T9B001X  T9H100X T0C069X  T8A061X  T8F047X  T9B004X  T9H101X T0C070X  T8B003X  T8F077X  T9B005X  T9H113X T0C103X  T8B037X  T8H001X  T9B038X  T9H114X T0D054X  T8B038X  T8H002X  T9C007X  T9J030X T0D059X  T8B039X  T8H003X  T9C008X  T9J035X T0D061X  T8B040X  T8H005X  T9C069X  T9J048X T0D115X  T8B041X  T8H006X  T9C070X  T9J073X T0E050X  T8C012X  T8H019X  T9C071X  T9J096X T7F019X  T8C034X  T8H051X  T9C156X  T9J097X T7F021X  T8C035X  T8H052X  T9E030X  T9J098X T7F022X  T8C041X  T8H072X  T9E069X  T9K002X T7J003X  T8C042X  T8J027X  T9E070X  T9K068X T7J004X  T8C044X  T8J038X  T9E071X  T9K104X T7J005X  T8D011X  T8J041X  T9E072X  T9K105X T7J013X  T8D057X  T8J042X  T9E111X  T9L019X T7J020X  T8D058X  T8J058X  T9E119X  T9L074X T7J032X  T8D059X  T8J067X  T9E120X  T9L075X T7L028X  T8D060X  T8K007X  T9F026X  T9L102X T7L029X  T8D061X  T8K009X  T9F049X  T9L103X T7L030X  T8D062X  T8K043X  T9F050X  T9M109X T7L048X  T8E047X  T8K050X  T9F078X  T9M110X T7L049X
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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