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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm January 13, 2021
Create Date February 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-1142-2021
Recall Event ID 87179
510(K)Number K173796  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL

Code Information Lot Number: SUH0709M
Recalling Firm/
Manufacturer
Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Catherine T. Wrenn
508-261-8000
Manufacturer Reason
for Recall
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
FDA Determined
Cause 2
Under Investigation by firm
Action Medtronic issued Urgent Medical Device Recall letter via Federal Express and/or certified mail beginning January 13, 2021. The letter states reason for recall, health risk and action to take:: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Parietex" Hydrophilic Anatomical Mesh. " Complete the Recalled Product Return Form. Inventory within Medtronic control and customer returned products will be scrapped. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 129 units WW
Distribution Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
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 = FTL and Original Applicant = Sofradim Production
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