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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Endo Clinch II

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  Class 2 Device Recall Covidien Endo Clinch II see related information
Date Initiated by Firm March 13, 2019
Create Date April 23, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-1211-2019
Recall Event ID 82426
510(K)Number K903205  
Product Classification Forceps, obstetrical - Product Code HDA
Product Covidien Endo Clinch II Auto Suture Grasper, 5mm
REF: 174317

The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
Code Information Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX 
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact SAME
508-261-8000
Manufacturer Reason
for Recall		 Sterilization method used was not consistent with the labeling and the approved sterilization method
FDA Determined
Cause 2		 Process control
Action Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, 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. -----If you have inventory email to: feedback.customerservice@covidien.com fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to GMBFCAMITG@Medtronic.com If purchased by distributor, fax to 203-492-7719 or email GMBFCAMITG@Medtronic.com. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 7248 units
Distribution Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HDA and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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