Covidien recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion due to excessive silicone lubricant. Affected units may cause blockages or clotting risks during dialysis.
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 a specific type of dialysis catheter that may have an occlusion (blockage) at the tip due to excessive silicone lubricant. This could lead to blockages, reduced blood flow, or clotting risks during dialysis treatments.
The catheter tip can become blocked by silicone lubricant (MDX) that coats it. This blockage may cause partial or full catheter obstruction, reducing blood flow or leading to clots, which can delay treatment or cause serious complications.
Patients receiving dialysis treatments using this specific catheter model are most at risk. Healthcare providers who use the catheter for acute dialysis procedures may also be affected.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray' with the reference number 8888102003HP. The lot numbers 2204000239 and 2227800110 are also associated with this recall.
Identify the model name and reference number on the catheter packaging or label.
Reach out to your healthcare provider to determine if you have the recalled catheter model and whether a replacement is needed.
The recall states that excessive silicone lubricant can cause blockages, but the catheter is safe if used correctly without the lubricant issue.
Look for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray' with reference number 8888102003HP and lot numbers 2204000239 or 2227800110.
No, but you should check with your healthcare provider to determine if the catheter needs replacement due to potential blockages.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2371-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2371-2023 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.
