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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic

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  Class 1 Device Recall Medtronic see related information
Date Initiated by Firm June 28, 2023
Date Posted August 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2376-2023
Recall Event ID 92660
510(K)Number K102605  K020089  
Product Classification Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
Product MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray

REF: 8888104003HP
Code Information GTIN: 20884521128054 LOT Numbers: 2131200173 2133700237 2200400273 2200400290
Recalling Firm/
Manufacturer
Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Dori Estrella-Sands
763-505-2670
Manufacturer Reason
for Recall
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
FDA Determined
Cause 2
Process control
Action Medtronic issued Urgent Medical Device Recall letter beginning on June 28, 2023. Letter states reason for recall, health risk and action to take: To help you identify if you have affected product, please visit our website www.Medtronic.com/Mahurkar-Triple-Lumen-Catheter-Recall. Here you will find a tool to help you determine if the product you have is affected by this recall. 2. Immediately quarantine and discontinue use of all unused Mahurkar TM Acute Triple Lumen Catheters and Mahurkar TM Acute High Pressure Triple Lumen Catheters referenced in Attachment B - List of affected Lot numbers (see Attachment A for guidance to identify impacted product). Note: This recall does not include Mahurkar Elite Catheters. 3. Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. Link: https://www.novasyte.com/medtronic/fa1333 Note: Please complete the online Customer Confirmation Form even if you DO NOT have affected product. 4. If you have affected product, it must be returned for processing. Upon completion of the online Customer Confirmation Form, Customer Service will contact you with an RGA number to return all unused affected Mahurkar TM Acute Triple Lumen Catheters and Mahurkar TM Acute High Pressure Triple Lumen Catheters from your inventory to Medtronic. 5. This notice should be passed on to all those who need to be aware within your organization or to any organization including but not limited to Nephrologists, Intensivists, physicians, renal nurses, critical care nurses, or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Medtronic has partnered with Novasyte, an IQVIA company, to assist in this recall. For assistance regarding online response processing or product return for this recall, please contact Novas
Quantity in Commerce 1099 units
Distribution US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic Finland France French Polynesia Germany Greece Hungary India Iran, Islamic Republic Of Ireland Italy Kuwait Malaysia Maldives Mauritius Mexico Nepal Netherlands New Caledonia Nicaragua Norway Philippines Poland Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Thailand Turkey United Arab Emirates 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 = NIE and Original Applicant = COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
510(K)s with Product Code = NIE and Original Applicant = THE KENDALL COMPANY
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