Covidien recalls 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters with potential occlusion from excessive silicone lubricant. Affected units may cause blockages 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 a specific type of dialysis catheter due to a risk of blockages from excessive silicone lubricant. This could delay treatment or cause blood clots in patients needing dialysis.
The catheter tip can become blocked by silicone lubricant (MDX) that coats it. This blockage may cause treatment delays, reduced blood flow, or blood clots that could lead to serious complications.
Patients using this dialysis catheter for acute kidney failure treatment are most at risk. Healthcare providers who use the catheter for temporary dialysis are also affected.
Check for the model: 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray. The reference number is 8888102004HP with lot numbers starting with 2200400154.
If you experience reduced blood flow or treatment delays, contact your healthcare provider immediately.
Reach out to Covidien for guidance on whether your catheter is affected and next steps.
The recall indicates a potential risk of blockages from silicone lubricant, so it is not safe to use without checking with the manufacturer.
Check for the model: 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray with reference number 8888102004HP and lot numbers starting with 2200400154.
Contact Covidien directly for specific guidance on whether your catheter is affected and what actions to take.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2372-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2372-2023 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.
