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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Endo GIA Ultra Universal stapler

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  Class 2 Device Recall Covidien Endo GIA Ultra Universal stapler see related information
Date Initiated by Firm January 17, 2020
Create Date February 18, 2020
Recall Status1 Open3, Classified
Recall Number Z-1264-2020
Recall Event ID 84811
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery
Item Code: EGIAUSTND
Code Information Lot Number: P9E0022Y
Recalling Firm/
Manufacturer
COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact See Above
508-261-8000
Manufacturer Reason
for Recall
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
FDA Determined
Cause 2
Package design/selection
Action Medtronic notified consignees by letter via Federal Express and/or certified mail beginning January 17, 2020. The letter informs of the reason for recall, health risk and action to take: Immediately quarantine and discontinue use of the affected itemcode and lot; " Return affected product; Forward the information to anyone who they have distributed. Complete the Recalled Product Return Form even if you do not have inventory. Questions: Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com.
Quantity in Commerce 2,180 units
Distribution US Nationwide, Israel, and Japan
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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