Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk
Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.
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 classification requires minimum severity level 4 (Severe). The defect can cause complete catheter obstruction with potential for serious complications including embolism and thrombosis.
Plain-English summary
Covidien LP is recalling 5,373 units of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (REF: 8888101003HP). The affected units were distributed nationally in the United States and internationally in multiple countries. The lot numbers affected are 2130900104, 2133600083, 2133600160, 2133600165, 2226500171, 2226500173, 2227800101, 2227800104, 2227800109, and 2230400208.
The FDA classified this as a Class I recall because examination of the affected catheters revealed occlusions in the center lumen tip caused by excessive amounts of MDX, a silicone-based lubricant coating. The excessive, uncured, or partially cured lubricant may dislodge from the catheter tip.
Full or partial dislodgement of the MDX can result in complete or partial obstruction of the catheter lumen. Complete obstruction can cause delay to patient treatment. Partial obstruction can reduce flow rates. Dislodged lubricant particles may lead to hemolysis (damage to red blood cells), embolism (blood clots in blood vessels), or thrombosis (formation of blood clots).
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- treatment-delay
- hemolysis
- embolism
- thrombosis
Distribution
Distributed nationwide across the United States.
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