Dialysis Catheters Recalled for Catheter Obstruction from Excessive Silicone Lubricant
Covidien is recalling 1,875 MAHURKAR dialysis catheters with lot numbers 2204000239 and 2227800110 due to excessive silicone lubricant causing catheter obstruction. The obstruction may delay treatment or cause hemolysis and thrombosis.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA has classified this as a Class I recall, which mandates a minimum severity score of 4. The hazard involves potential for serious complications including thrombosis, embolism, and hemolysis from catheter obstruction, which could delay critical dialysis treatment.
Plain-English summary
Covidien LP is recalling 1,875 units of the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (Reference Number 8888102003HP) distributed in the United States and internationally. The affected lots are 2204000239 and 2227800110 (GTIN: 20884521127996).
The catheter center lumen contains an occlusion at the catheter tip caused by excessive MDX, a silicone-based lubricant used to coat the catheter. An occluded or partially occluded tip may dislodge from the catheter, leading to full or partial catheter obstruction.
A fully obstructed catheter may delay dialysis treatment. A partially obstructed catheter may reduce blood flow. Particulate matter released from the dislodged lubricant may cause hemolysis, embolism, or thrombosis. These conditions require immediate medical attention.
Patients and healthcare providers should stop using affected catheters immediately and consult with their healthcare provider. The FDA has classified this as a Class I recall due to the serious risk to patient health.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
- Manufacturer
- Covidien LP
- Affected units
- 1,875
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: 20884521127996 LOT Numbers: 2204000239 2227800110
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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