Hospira recall
This article was originally published in The Gray Sheet
Executive Summary
Firm says models of its Symbiq one-channel and two-channel infusion pumps may fail to detect air in the line at the end of an infusion. Delivering air to patients could result in serious injury or death, Hospira notes. FDA classified the recall as Class I, the most serious category, on July 15. Hospira first alerted customers to the problem in April, and gave updated recommendations on June 11. Among them, users should not use polyethylene-lined microbore segment administration sets if other sets are available and should not run solution/medication containers dry; and they should enable the "nearing end of infusion" alarm on the devices or use an "air eliminating filter," if appropriate, the firm recommends. Symbiq pumps can still be used while a permanent fix is identified. Hospira had halted shipments in April to investigate customer complaints (1"The Gray Sheet" May 10, 2010)
You may also be interested in...
Mandatory Baxter Infusion Pump Recall Will Cost Up To $600 Million
Baxter will recall all of its Colleague infusion pumps on the U.S. market at an initial cost of up to $600 million, the firm disclosed May 3
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.