Covidien recalls specific dialysis catheters with potential occlusion from excessive silicone lubricant, risking blockage and treatment delays. Affected units include model 8888345611HP with certain lot numbers.
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 specific dialysis catheters that may have an occlusion (blockage) at the tip due to excessive silicone lubricant. This can cause blockages, reduced blood flow, or even clotting, delaying critical treatment for kidney failure.
The catheter tip may become blocked by silicone-based lubricant (MDX) that coats the tip. This blockage can cause partial or full catheter obstruction, reducing blood flow or leading to clots, which may delay life-saving dialysis treatments.
Healthcare professionals 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 number 8888345611HP on the catheter kit. The lot numbers listed in the recall include 1908400297 through 2234800070. These catheters were sold with specific GTINs and lot numbers.
Look for the lot numbers listed in the recall (1908400297 to 2234800070) on the catheter kit packaging.
The catheter tip may become blocked by excessive silicone lubricant (MDX), which can cause blockages, reduced blood flow, or clots, delaying critical dialysis treatment.
Check the lot number on the catheter kit packaging to see if it's in the affected list. If it is, contact your healthcare provider for guidance.
The recall record does not specify a remedy, so no action is required beyond checking the lot number and consulting your healthcare provider.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2387-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2387-2023 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.
