Covidien LP Recall 92660
Description: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
Covidien LP Recall 92660 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2391-2023 |
| Event ID | 92660 |
| Event Description | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP |
| Product Type | Devices |
| 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 |
| Recall 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 |
| Device Classification | 20230823 |
| Device Code Info | GTIN: 10884521128187 / 20884521128184 LOT Numbers: 1916500156 2017400085 2028300088 2102600094 2104600149 2107700145 2113100057 2119400230 2123000100 2133700164 |
| Center Classification Date | 20230811 |
| Recall Initiation Date | 20230628 |
| Recalling Firm | Covidien LP |
| Initial Notification | Letter |
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