Company: Zyno Medical LLC Date of Enforcement Report: 11/22/2024 Class: III PRODUCT Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional. Recall...Read More

WARNING LETTER Randox Laboratories Limited was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 696569 30 Randalstown Road Antrim BT41 4FL United Kingdom Dates: August 5, 2024 through August 8, 2024 Inspection Issue(s): The report states that “the RX series test systems, including the RX daytona,...Read More

WARNING LETTER Becton, Dickinson, and Company/CareFusion was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 691601 Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes, NJ 07417United States Dates: May 6, 2024 through May 22, 2024 Inspection Issue(s): Report states, “your firm manufactures Pyxis Medication...Read More