BEUDAMED
    FDA Enforcement Class I Ongoing

    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP

    Recall: Z-2389-2023 · Reported August 23, 2023

    Enforcement

    Recall Number
    Z-2389-2023
    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, 20 cm, Curved Extensions, Kit REF: 8888345629HP

    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: 0884521128163/ 20884521128160 LOT Numbers: Lot Number 1828200086 1925300170 1925300171 2018800013 2018800024 2018800043 2019500199 2019500200 2019500222 2021000106 2021000107 2029600102 2029600103 2116600083 2131200176 2133700166 2227800108 2230400250 2230400251 2234800071

    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

    15209 units