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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 staplersee related information
Date Initiated by FirmJanuary 17, 2020
Create DateFebruary 18, 2020
Recall Status1 Terminated 3 on July 29, 2022
Recall NumberZ-1264-2020
Recall Event ID 84811
510(K)NumberK111825 
Product Classification Staple, implantable - Product Code GDW
ProductCovidien 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 ContactSee 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
ActionMedtronic 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 Commerce2,180 units
DistributionUS Nationwide, Israel, and Japan
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GDW
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