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Recall Category: Medical Device Recalls
Recalling Firm: Covidien LP
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
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
Classification: Class I
Status: Ongoing
Report Date: 08/23/2023
Recall Initiation Date: 06/28/2023
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
Code Info: GTIN: 20884521128009 LOT Numbers: 2200400154
Product Quantity: 685 units
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: Letter
Firm Location: Mansfield, MA, United States
Recall Number: Z-2372-2023
Event ID: 92660