Dialysis catheter recalled due to potential tip occlusion risk
Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant in the catheter tip, potentially causing obstruction. This could delay treatment or cause serious blood complications including thrombosis or embolism.
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, which mandates a minimum severity of 4. Although no illnesses or injuries have been reported, the product defect poses serious risks including potential treatment delay and serious complications such as embolism and thrombosis in hemodialysis patients.
Plain-English summary
Covidien LP is recalling 1,325 units of the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (model REF: 8888101004HP) distributed nationwide and internationally. The affected products were manufactured under lot numbers 2130900107 and 2133700059.
The center lumen of affected catheters contains excessive MDX, a silicone-based lubricant that coats the catheter tip. This lubricant may be uncured or may dislodge from the catheter tip during use.
An occluded center lumen—whether partially or fully blocked—may prevent adequate blood flow and delay dialysis treatment. Dislodged lubricant particles or partial obstruction could result in hemolysis, embolism, or thrombosis, all serious complications for hemodialysis patients.
Patients and healthcare providers who have received this product should stop using it and contact Covidien LP for replacement instructions. Anyone who has experienced symptoms related to use of this catheter should consult their healthcare provider.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- embolism
- thrombosis
- hemolysis
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: 20884521127989 LOT Numbers: 2130900107 2133700059
Distribution
Distributed nationwide across the United States.
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