Baxter’s Ipump returns
This article was originally published in The Gray Sheet
Executive Summary
Firm will resume sales of Ipump pain management infusion pumps in the second quarter after announcing 510(k) clearance of an upgraded version Feb. 6. Baxter had placed Ipump "on hold" in July 2005 while it developed hardware and software to reduce error codes and improve programming. The firm is making similar improvements to its Colleague and Syndeo infusion pumps. The latter malfunction-prone devices have been off the market since a seizure by FDA in October 2005, followed by a June consent decree forbidding their sale until Baxter gets its manufacturing system back into compliance. The firm announced a 510(k) filing for an updated Colleague and approval of a corrective action plan in December (1"The Gray Sheet" Dec. 18, 2006, In Brief)...