Class I Recall of Baxter In-Home Dialysis Device Announced | DC Metro Area Medical Malpractice Law Blog

Posted by: Salvatore J. Zambri, founding partner

According to the Chicago Tribune, Baxter International Inc. announced a recall of its “in-home dialysis device that has been linked to serious injury reports and at least one death in the last two years.” In addition, the “Food and Drug Administration has classified the action as a Class I recall, the agency’s most serious, for the Baxter’s HomeChoice and HomeChoice Pro peritoneal dialysis cyclers, because the device is causing an ‘overfill’ of fluid in the patient’s stomach,” states the Tribune report.

A Class I recall applies to problems that can cause serious adverse health consequences or death. According to an AP report, “Baxter said it is still investigating the source of the problems and is working on changes to labeling and software to prevent patient errors.”  The company nevertheless claims that the “machines do not need to be physically returned to the company and can still be used.”

Dow Jones Newswire reported on the recall as well.

If using a Baxter device, we urge you to speak with your doctor immediately to determine if it is safe for you to continue using it.  Your doctor should be aware of the problems and the consequential risks to be able to provide you with the information you need to make the best decision possible for your health.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area.  The magazine also described him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been repeatedly named a “Super Lawyer” by Law and Politics magazine–a national publication that honors the top lawyers in America.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books – a company that is touted as “the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world’s most respected companies and law firms.”  To read Mr. Zambri’s publication, entitled “Constantly Preparing To Win”, please click here.

If you have any questions about your legal rights, please email Mr. Zambri at or call him at 202-822-1899.