Dialysis cartridges used in the NxStage’s System One portable dialysis machine have been recalled due to potential dialysate leaks. The dialysis machines are used in 265 clinics around the country.
After discussing the leakage issue with the U.S. Food and Drug Administration, NxStage said in the SEC filing that it decided on August 24 to physically recall the affected lots of cartridge inventory being used by customers and patients, who would receive replacement cartridges at no charge. In addition, NxStage told patient and customers to destroy all affected cartridges.
The recall may cost the company $2.5 Million to replace all of the faulty cartridges. They may have a short term delay in getting new cartridges to clinics.