FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

Date Issued: April 18, 2012 Audience: Hospital and clinic administrators, risk managers, infection control practitioners, purchasing departments, surgical centers, medical offices. Health care professionals using or referring patients for ultrasound procedures (e.g., radiologists, urologists, gastroenterologists, obstetricians/gynecologists, internists, chiropractors, nurses, physical therapists, and sonographers). Product: Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. is…

Consumer Information on: LINX? Reflux Management System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: LINXâ„¢ Reflux Management SystemPMA Applicant:…