Despite seizures and repeated warning letters from the FDA, the healthcare giant just never convinced anyone that its Alaris Signature Edition infusion pumps were safe and reliable.

Now, the FDA says Cardinal must stop making and distributing the pump until manufacturing problems are corrected. Who knows when that will happen. The decree was entered yesterday in U.S. District Court for the Southern District of California.

The FDA previously decided the situation was so out of hand that there was a “reasonable probability that use or exposure….will cause serious adverse health consequences or death.” An FDA spokeswoman called to say no deaths were recorded.

During the past 12 years, about 140,000 pumps were distributed worldwide, but Cardinal was quick to note that it accounts for less than 1 percent of revenue for Cardinal’s technology unit. Cardinal earlier disclosed $13.5 million was reserved this year to cover the costs associated with turning things around.

Ever the gracious executive, Dave Schlotterbeck, who heads Cardinal’s pharmaceutical and medical products biz, says the company is “pleased” to enter this agreement.

Interesting choice of words. Maybe he’s pleased he still has his job.

[tags]Cardinal Health, Consent Decree, FDA, Infusion Pumps[/tags]