Covidien recalls specific 12Fr high-pressure triple lumen dialysis catheters due to silicone lubricant causing tip occlusion, potentially leading to 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 certain 12Fr high-pressure triple lumen acute dialysis catheters because a silicone-based lubricant can cause blockages at the catheter tip. This may delay treatment or cause complications like reduced blood flow or blood clots.
The catheter tip can become blocked by excessive silicone lubricant (MDX), which may cause partial or full blockages. This can lead to reduced blood flow, treatment delays, or even blood clots if the blockage is severe.
Healthcare providers using the recalled catheters for acute dialysis treatments are most at risk. Patients receiving dialysis through these catheters could face treatment delays or complications.
Check for the model: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray with REF: 8888101002HP. Lot numbers 2133600171 through 2233400068 are affected.
Verify the model and lot numbers listed in the recall notice to determine if your catheter is affected.
The recall indicates a risk of blockage from silicone lubricant, so it is not safe to use without checking the recall list.
Check the model and lot numbers against the recall list provided by the manufacturer to see if it is affected.
The recall does not specify a remedy, so you should check the list to determine if it is affected before using.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2368-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2368-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
