Covidien recalls MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters with potential occlusion from excessive silicone lubricant. Affected units may cause treatment delays or complications.
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 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters that may have an occlusion (blockage) at the catheter tip due to excessive silicone lubricant. This could lead to treatment delays, reduced blood flow, or serious complications like blood clots or embolisms.
The catheter tip can become blocked by excessive silicone-based lubricant (MDX), which may cause partial or full blockage. This blockage can delay treatment, reduce blood flow, or lead to blood clots, embolisms, or other serious complications.
Patients receiving hemodialysis treatments using the recalled catheters are most at risk. Healthcare providers who use these catheters for acute dialysis treatments may also be affected.
Check for the MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter with 20 cm curved extensions. Lot numbers include 2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, and 2127300113.
Look for the lot numbers listed in the recall notice: 2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, and 2127300113.
The recall indicates the catheter may have an occlusion risk from excessive silicone lubricant, so it is not safe to use without checking the lot number.
Check the lot number against the list provided in the recall notice. If it matches, contact your healthcare provider for guidance.
The affected catheters have specific lot numbers listed in the recall notice: 2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, and 2127300113.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2388-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2388-2023 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.
