Covidien recalls specific dialysis catheters with potential occlusion risk from 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 can lead to treatment delays, reduced blood flow, or complications like blood clots or embolisms.
The catheter tip can become blocked by silicone lubricant, causing partial or full blockages. This may lead to reduced blood flow, treatment delays, or the risk of blood clots, embolisms, or other complications.
Healthcare providers using the recalled catheters for acute dialysis treatments are most at risk. Patients receiving dialysis with these catheters could experience treatment delays or complications.
Check for the model name 'MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit' with the reference number REF: 8888345603HP. Lot numbers 2017400081, 2028300087, 2113300282, 2133700046, and 2227800105 are affected.
Identify the model name and reference number to confirm if your catheter is affected.
Reach out to Covidien for guidance on next steps if your catheter is recalled.
The catheter tip may become blocked by excessive silicone lubricant, leading to treatment delays or complications.
Check the model and reference number to see if it's affected. Contact Covidien for further instructions.
The recall addresses potential treatment delays and complications, but does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2385-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2385-2023 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.
