| Subject: | FDA Class I Recall of Baxter Healthcare Corp. Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Fri, 20 Jul 2007 - 01:00 pm |
| The FDA has issued a notice regarding the Class I recall of Baxter Healthcare Corporation's Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, model numbers:2M81532M81632M9163A software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. In reported cases, the pump stopped... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
RESOURCES:
Customizable Documents and Tools:
External Links:
|
|
StayAlert!® Virtual Compliance Administrator™ keeps clients informed by email of any changes to Federal regulations, including Joint Commission (TJC, formerly JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG, and many more, and also provides downloadable tools to ensure compliance. StayAlert! is a premium product sold as an annual site-license subscription. With the site license, the client can sign up an unlimited number of users for the email alerts and access to the StayAlert! online regulatory library. Other vendors have components of legislated requirements available online or on CD-ROM. However there is no other product that marries regulatory agency mandates with implementation tools, making the latest compliance information immediately available online. No other product provides an interpretative analysis, followed by a practical application tool, therefore providing users with an immediate solution to compliance problems. StayAlert! includes operational components for healthcare organizations, allowing complete facility compliance with mandated requirements, online. |
|