Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)...
Advertisement

Related Content

Baxter’s Colleague moves ahead
Advertisement
UsernamePublicRestriction

Register

MT024474

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel