Acute Dialysis Catheters Recalled for Catheter Tip Occlusion
Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.
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 a minimum severity score of 4. While no patient illnesses or injuries have been reported, the defect poses significant risk of serious complications including hemolysis, embolism, and thrombosis during dialysis treatment.
Plain-English summary
Covidien LP is recalling MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (Reference 8888104004HP, Lot 2200400292) due to a manufacturing defect. A total of 519 units are affected by this recall.
The center lumen of the catheter was found to have an occlusion at the tip caused by excessive MDX, a silicone-based lubricant that coats the catheter. An occluded catheter—partially or fully—may impede blood flow during dialysis treatment.
Excessive or incompletely cured MDX lubricant may dislodge from the catheter tip, potentially causing complete obstruction and treatment delay, or partial obstruction with reduced blood flow. Complications may include hemolysis, embolism, or thrombosis.
The affected lot was distributed nationwide in the United States and internationally to multiple countries. This is an FDA Class I recall.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
- Manufacturer
- Covidien LP
- Affected units
- 519
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: 20884521128061 LOT Numbers: 2200400292
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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