Dialysis catheter recall: excessive lubricant causes center lumen obstruction
A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Regulatory criteria establish that Class I recalls must receive a minimum score of 4. Though no illnesses have been reported, the confirmed manufacturing defect poses serious risks including thromboembolism and hemolysis.
Plain-English summary
The U.S. Food and Drug Administration has classified this as a Class I recall of MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters (reference 8888340629), manufactured by Covidien LP. The recall affects 655 units that were distributed nationwide and internationally.
The center lumen of these catheters contains an excessive amount of MDX, a silicone-based lubricant. This excessive coating can create a partial or complete occlusion (blockage) in the catheter tip, preventing or significantly reducing fluid flow through the catheter.
A fully or partially occluded catheter can delay dialysis treatment. If the excessive lubricant becomes dislodged, the particulate material may circulate in the bloodstream, potentially causing hemolysis (destruction of red blood cells), embolism (arterial or venous blockage), or thrombosis (blood clot formation).
The recalled product
- Product
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- hemolysis
- thromboembolism
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 20884521057019 LOT Numbers: 1921300069 2227800100
Distribution
Distributed nationwide across the United States.
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