The Food & Drug Administration issued its final order for the U.S. recall of Baxter International Inc.’s (NYSE:BAX) Colleague infusion pumps.
The federal watchdog is requiring the Deerfield, Ill.-based company to provide transition guide for hospitals and clinics using Colleague infusion pumps.
The guide will include a list of FDA-cleared or approved pump alternatives and information on refund, replacement and lease termination programs, the regulatory agency said.
Baxter will carry out the the recall over the next two years. The company said it will offer replacement infusion pumps or refunds to owners of Colleague pumps, and it is offering Sigma Spectrum pumps in exchange for the recalled pumps. Otherwise, owners can collect on the Colleague’s depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, according to the company. Pump lessees can terminate their leases without penalty.
The recall is the latest in a series of unfortunate news for the company. In June, FDA warned Baxter over the watchdog agency’s concerns about the company’s HomeChoice peritoneal dialysis systems, after reports surfaced of at least four patients developing peritonitis. It wasn’t the first time the HomeChoice system has created serious problems for patients. In March, the FDA issued a Class 1 recall for several models of the device, saying a problem with the dialysis machine is causing “increased intraperitoneal volume” or an overfill of the abdominal cavity with liquid, leading to injuries and at least one reported death.
