For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”.  This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 2/27/2019 Class II: PRODUCT AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. Recall Number: Z-0849-2019 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic...Read More

Company: Leica Microsystems, Inc. Date of Enforcement Report: 2/27/2019 Class II: PRODUCT PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. Recall Number: Z-0838-2019 REASON The observed issues can lead to unexpected...Read More