June 15, 1997
McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9. REASON The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set. CODE Serial Numbers: P61145, P71108, P71115, P71125, P71130,...
Read More

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.