Eco-Med Pharmaceuticals Inc. yesterday recalled a nonsterile ultrasound gel distributed under various brand names, including EcoGel and MediChoice, instructing health care facilities to immediately destroy or return the products due to contamination with the bacteria Burkholderia cepacia complex (Bcc).
The Centers for Disease Control and Prevention is assisting the Food and Drug Administration and several state and local health departments with an ongoing investigation of Bcc infections in health care facilities. It said patients have developed Bcc infections (including bloodstream infections) after ultrasound-guided procedures that used the MediChoice M500812 ultrasound gel.
CDC advises health care facilities to always use single-use, sterile ultrasound gel packets for ultrasonography used in preparation for or during transcutaneous procedures, such as placement of central and peripheral intravenous lines, amniocentesis and paracentesis. This includes avoiding nonsterile ultrasound gel for visualization prior to such procedures (e.g., vein marking, visualizing ascites).
Health care facilities should report any patient infections to FDA’s MedWatch program.