Medtech Insight is part 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


Alaris infusion pump recall

This article was originally published in The Gray Sheet

Executive Summary

CareFusion, which will soon spin off from parent firm Cardinal Health, is updating the software and directions for use for certain Alaris infusion pumps in a June 12 voluntary recall that FDA classified on Aug. 5 as Class I, the most serious category. Cardinal Health/CareFusion received 510(k) clearance for the software update in July and will provide it to customers within 60 days. Devices may have problems with pump warning messages, protection circuitry or components of the pumping mechanism that could lead to improper infusion therapy. In June, users were given risk mitigation steps to avoid overdosing until the software update arrives. CareFusion is setting aside $18 million for the corrective action, which could take a year to complete. Alaris pumps are currently subject to an FDA consent decree for manufacturing violations (1"The Gray Sheet" Feb. 23, 2009)

You may also be interested in...

Cardinal Health inks amended consent decree with FDA

Firm's amended consent decree with FDA expands its scope to include all Alaris infusion pumps, calling for the correction of good manufacturing practice violations. The pumps are made by a division of Cardinal Health formerly known as Alaris Medical Systems, which was acquired in 2004 and subject to the initial consent decree in February 2007 to resolve a 2006 seizure of Alaris SE infusion pumps (1"The Gray Sheet" Feb. 12, 2007, p. 5). FDA alleges in the amended consent decree that based on a January 2008 inspection, certain Cardinal Health infusion pumps do not satisfy agency standards, according to Cardinal. The firm says it implemented a new quality system in April 2008. Now the firm must hire an independent expert consultant to inspect all of its infusion pump facilities and recall procedures, and certify to FDA that corrective actions have been made. The amended decree, which includes the Alaris System, Gemini and Med System III infusion pumps, remains subject to approval by the U.S. District Court for the Southern District of California. If there are "future violations," FDA says it may suspend manufacturing and distribution

EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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