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Covidien LP Recall 92660

Description: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP

Covidien LP Recall 92660 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2371-2023
Event ID92660
Event DescriptionMAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
Product TypeDevices
DistributionUS 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
Quantity1875 units
Recall ReasonCatheter 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
Device Classification20230823
Device Code InfoGTIN: 20884521127996 LOT Numbers: 2204000239 2227800110
Center Classification Date20230811
Recall Initiation Date20230628
Recalling FirmCovidien LP
Initial Notification Letter
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