Company: Verathon, Inc. Date of Enforcement Report 11/17/2010 Class ll: PRODUCT 1) BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into...Read More

Company:Baxter Healthcare, Corp Date of Enforcement Report 11/17/10//2010 Class l: PRODUCT ) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z-0001-2011; 2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes: 2M 8153 and 2M 8163. Recall # Z-0002-2011; REASON The FDA sent a letter to Baxter on...Read More