Covidien LP Recall 92660
Description: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Covidien LP Recall 92660 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2384-2023 |
| Event ID | 92660 |
| Event Description | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603 |
| 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 | 45880 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: 10884521006768/ 20884521006765 LOT Numbers: 1907700093 1908400296 1914400157 1914400158 1914800241 1914800242 1914800243 1915800144 1915800145 1916500157 1920700126 1921100198 1921100199 1921100201 1921300056 1921300057 1928700083 1932300211 2000700063 2000700064 2001400084 2002100115 2002900099 2002900103 2002900104 2005700211 2005700212 2007800069 2007800070 2007800088 2009000047 2009400127 2010800201 2010800203 2010800204 2010800206 2010800207 2015100040 2015100043 2017400082 2019500192 2131200161 2131200162 2131200163 2227800106 2227800111 2227800112 2227800114 2227800115 2230400303 2230400304 2232700203 |
| Center Classification Date | 20230811 |
| Recall Initiation Date | 20230628 |
| Recalling Firm | Covidien LP |
| Initial Notification | Letter |
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