The Recall Desk
SevereFDA (Devices)·Z-1320-2022·Announced 2022-07-13

Dialysis Catheters Recalled for Potential Fluid Leakage from Hub Defect

Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.

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 score of 4. The potential for fluid leakage during critical dialysis treatment presents a risk of serious harm, though no deaths or hospitalizations are reported in the source text.

Plain-English summary

Covidien Llc is recalling Mahurkar Chronic Carbothane (Maxid) dialysis catheters, which are sterile, single-use devices designed for acute and chronic hemodialysis, apheresis, and infusion. Approximately 132,443 affected units have been distributed worldwide.

The catheters contain a potential leaking condition in the hub due to an inter-lumen void in the hub component. This defect may result in unanticipated fluid return during use, which could compromise patient safety during dialysis treatment.

The recall affects healthcare facilities and patients in the United States and numerous countries worldwide who received affected units. Multiple model numbers and serial numbers are involved in this recall.

Healthcare providers with affected units should stop using them immediately and contact Covidien Llc for instructions. Patients who have received these catheters should consult with their healthcare provider about the recall.

The recalled product

Product
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Manufacturer
Covidien Llc
Hazard
  • fluid-leakage
  • device-defect

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 (20)

  • Code Information organized as "Model No.
  • Serial No.
  • GTIN": 8888119362
  • 1928800230
  • 10884521056879
  • 8888119362
  • 1825400094
  • 20884521056876
  • 1912600107
  • 1917600139
  • 1917700080
  • 1925200098
  • 1927300146
  • 2023300144
  • 2028200216
  • 2122900239
  • 8888119385
  • 1720700105
  • 20884521012421
  • 1724900109

Distribution

Distributed nationwide across the United States.