Baxter cites death in recall of dialysis productDec 14, 2005 | Chicago Sun Times
Baxter, which sent an urgent recall letter to customers in September with instructions on how to address the issue, also said federal regulators have classified the letter as a Class 1 recall, the most serious kind.
The device is used to treat patients with kidney problems.
The problem relates to how tubing sets are routed through clips mounted on the front of the Meridian devices. If routed incorrectly, they can kink or bend, which can result in broken blood cells and cause serious injury or death.
The U.S. Food and Drug Administration's recall classification doesn't require the return of Meridian instruments in the market, Baxter said. Roughly 2,100 of the instruments are in use, including 1,700 in the United States.
Baxter said that to help customers address the problem, in September it provided labels to be attached to the Meridian units and asked that all care providers be trained in the proper setup and monitoring of the devices.
In July, Baxter said it would no longer make any hemodialysis instruments, and the company has been working to transition customers to alternate hemodialysis instruments through a distribution arrangement with Gambro Renal Products.
The last Meridian instrument was made in 2002.