MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP

This recall is currently active, issued August 11, 2023.

Recall Initiated: June 28, 2023
Posted: August 11, 2023
Recall Number: Z-2368-2023
Quantity: 6615
Firm Location: Mansfield, MA
Official Source: View on FDA website ↗

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

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

Lot / Code Info

GTIN: 20884521127965 LOT Numbers: 2133600171 2133600172 2133700047 2133700048 2133700060 2200400110 2204000236 2230400213 2230400214 2233400068

Root Cause

Process control

Action Taken

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