FDA Device recall Z-2379-2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
- 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, 20 cm, Straight Extensions, Kit REF: 8888340629HP 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-2379-2023 |
| 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, 20 cm, Straight Extensions, Kit REF: 8888340629HP
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: 10884521128071, 20884521128078 LOT Numbers: 1926100313 1926100314 1926100315 1933000064 2034900046 2102200138 210…GTIN: 10884521128071, 20884521128078 LOT Numbers: 1926100313 1926100314 1926100315 1933000064 2034900046 2102200138 2107700127 2113300296 2119400212 2123000099 2130800131 2203300174 2230400227 |
|---|
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-2379-2023%22
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