The Recall Desk
SevereFDA (Devices)·Z-2371-2023·Announced 2023-08-23

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.

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 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
Category
Medical Device — Dialysis Catheter
Hazard
  • catheter-obstruction
  • thrombosis
  • embolism
  • 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: 20884521127996 LOT Numbers: 2204000239 2227800110

Distribution

Distributed nationwide across the United States.

Related recalls

Same category