Recall Z-2368-2023 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
| Date | Aug 11, 2023 (initiated Jun 28, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 (se |
| Quantity | 6615 |
| 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 Ital |
| FDA record | Open on fda.gov |