Covidien recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion from excessive silicone lubricant. Affected units may cause delays in treatment or blood clots.
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
Covidien is recalling certain dialysis catheters that may have an occlusion (blockage) at the tip due to excessive silicone lubricant. This could lead to treatment delays, reduced blood flow, or blood clots if the catheter becomes blocked.
The catheter tip can become blocked by silicone lubricant (MDX) that coats it. This blockage might cause treatment delays, reduced blood flow, or blood clots if the catheter becomes obstructed.
Patients receiving dialysis and healthcare providers who use these catheters are most at risk. The specific model and lot numbers are listed in the recall notice.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions' and lot numbers 2018800011 or 2203900129.
Inspect the catheter for signs of blockage, such as reduced blood flow or treatment delays.
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions with lot numbers 2018800011 or 2203900129.
The catheter tip may have an occlusion due to excessive silicone lubricant (MDX), which can cause blockages, treatment delays, or blood clots.
Check for blockage signs and contact your healthcare provider for guidance on next steps.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2383-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2383-2023 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
