FDA Device recall Z-2367-2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
- FDA Device
- Class I
- ongoing
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class I recall of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP by Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2367-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-28 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
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
Identifiers
| code_info | GTIN:20884521127897 LOT Numbers: 2133600127 2133700049 2200400180 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2367-2023%22
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