Baxter-Colleague-3-channel-pump

Baxter just can't seem to get a break. Just 4 months after their Colleague pump comes off ship hold (more here), Baxter and the FDA announce new recalls.

The FDA upgraded Baxter's recall of the 3 channel Colleague pump to a Class I recall (the most serious) for a software bug. Here's Baxter's press release and the FDA's notice.

On top of all this, Baxter employees at a Phoenix service center have been caught falsifying records regarding the service and repair of 534 recalled Colleague and Flo-Gard pumps. From Baxter's home town paper, the Chicago Sun-Times:

Baxter spokeswoman Deborah Spak said the latest recall is different
from earlier recalls. "This has nothing to do with the Colleague
remediation. The reality is that on an ongoing basis any company is
going to have [FDA] field corrective actions and recalls. I think given
the visibility that we have received over the last few years related to
Colleague, something like this takes on more visibility than it
ordinarily would."

The recall followed the company's disclosure last week that it had
removed 4,500 of its Colleague triple-channel pumps from service after
receiving reports of injuries caused by life-threatening problems with
the recently manufactured or upgraded pumps. The pumps comprise only 25
percent of Baxter's total installed base of pumps, and the company said
its 200,000 single-channel and 75,000 non-upgraded triple-channel pumps
aren't affected by the problem.

Ouch. Pictured right is a Colleague triple-channel pump.

UPDATE: Here's the FDA recall notice for the pumps that had falsified repair, inspection & test data sheets mentioned above.