BEUDAMED
    FDA Enforcement Class I Ongoing

    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP

    Recall: Z-2391-2023 · Reported August 23, 2023

    Enforcement

    Recall Number
    Z-2391-2023
    Event ID
    92660
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 23, 2023
    Initiation Date
    June 28, 2023
    Classification Date
    August 11, 2023
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP

    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

    Code Info

    GTIN: 10884521128187 / 20884521128184 LOT Numbers: 1916500156 2017400085 2028300088 2102600094 2104600149 2107700145 2113100057 2119400230 2123000100 2133700164

    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

    Quantity

    3965 units