Dialysis Catheter Recall Due to Center Lumen Occlusion
Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.
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: This is an FDA Class I recall with no reported illnesses or injuries. The rubric mandates that FDA Class I recalls score no lower than 4 (Severe). The hazard is confirmed—excessive lubricant occlusion has been identified in the product—and poses serious risks including treatment delay and potentially life-threatening bloodstream complications for dialysis patients.
Plain-English summary
Covidien LP is recalling MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters, 20 cm with curved extensions (REF: 8888345629). The recall involves 6,949 units that were distributed nationally in the United States and to multiple countries worldwide.
The center lumen of the catheter was found to contain an occlusion at the catheter tip caused by excessive MDX, a silicone-based lubricant that coats the catheter. This excessive lubricant may not cure properly and could dislodge from the catheter, leading to full or partial catheter obstruction.
A fully or partially occluded catheter may delay dialysis treatment. Partial obstructions can reduce blood flow through the catheter. Dislodged lubricant particles may cause hemolysis (destruction of red blood cells), embolism (blood clots or particles traveling in the bloodstream), or thrombosis (blood clot formation), which are serious complications during dialysis treatment.
Affected lot numbers include: 2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, and 2127300113.
The recalled product
- Product
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
- Manufacturer
- Covidien LP
- Hazard
- occlusion
- hemolysis
- embolism
- thrombosis
Distribution
Distributed nationwide across the United States.
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