Covidien recalls MAHURKAR 12 Fr High Pressure 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 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 serious complications like blood clots or embolisms.
The catheter tip can become blocked by excessive silicone lubricant (MDX), which may cause partial or full blockages. This can delay treatment, reduce blood flow, or cause blood clots, embolisms, or other serious complications.
Patients receiving dialysis and healthcare providers using these catheters are affected. Those with the specific model and lot numbers are most at risk.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray' and lot number 2133700228. The product has a specific reference code (REF: 8888103001HP).
Inspect the catheter for signs of blockage at the tip, which may cause treatment delays or complications.
The recalled model is MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray with reference code REF: 8888103001HP.
Lot number 2133700228 is affected.
Check for the model name and lot number 2133700228 on the product label or documentation.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2373-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2373-2023 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.
