Baxter gets another Class I
This article was originally published in The Gray Sheet
Executive Summary
Baxter's Sept. 28 letter to customers regarding its Meridian hemodialysis instrument has been designated by FDA as a Class I recall, the firm announces Dec. 13. The letter was prompted by reports of broken blood cells related to kinks in the blood tubing sets. Customers were directed to route blood tubing through only one of the channels mounted on the front of the Meridian to reduce the risk of kinks. Three Baxter recalls of Colleague infusion pumps, which FDA seized in October, were designated as Class I earlier in 2005 (1"The Gray Sheet" Oct. 17, 2005, p. 3)...
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.