Recall of Ultrasound Gel Product for Burkholderia cepacia complex Contamination, and Call for Cases

Date:8/9/2021
Official Message No.:104503-8-9-2021-PHAD
Contact Info: Gabriel | Gabriel.Innes@doh.nj.gov
Jason | Jason.Mehr@doh.nj.gov
Attachments: No

Background: The Centers for Disease Control and Prevention (CDC) is assisting the Food and Drug Administration (FDA) and several state and local health departments with an ongoing investigation of Burkholderia cepacia complex (Bcc) infections in healthcare facilities. Patients have developed Bcc infections, including bloodstream infections, after having undergone ultrasound-guided procedures in which MediChoice® M500812 ultrasound gel was used. Additional ultrasound gel products listed under alternative names have unknown implications (see attached voluntary recall document). As of August 4, 2021, preliminary testing indicated the presence of Burkholderia stabilis, a species within Bcc, in 4 lots of unopened bottles of MediChoice® M500812 ultrasound gel. These B. stabilis product isolates genetically matched B. stabilis isolates obtained from at least 15 patients across multiple states. Additional laboratory testing of isolates or specimens from patients with reported Bcc infections and of additional lots of MediChoice® M500812 ultrasound gel is currently underway. Voluntary Product Recall Information: As of August 4, 2021, the manufacturer of MediChoice®M500812 ultrasound gel (Eco-Med Pharmaceutical, Etobicoke, ON, Canada) has issued a recall of Eco-Gel 200® ultrasound gel (also labeled as MediChoice® M500812, among others) with lots: B029, B030, B031, B032, B040, B041, B048, B055. Per the manufacturer: “Eco-Med is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med…Additionally, Eco-Med is instructing all health care facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under [Eco-Med brand names, including Eco-Gel, MediChoice, Red Medical, and DJO] brand names.” Please refer to https://eco-med.com/recall/ for additional information, including a list of the brand names. Recommendations: Healthcare facilities should be on alert and contact NJDOH CDS staff (listed below) to report any of the following: • Culture from ANY body site with B. stabilis in a specimen collected from a patient on or after January 1, 2021, OR • Culture from ANY body site with Bcc (with no species identification) in a specimen collected from a patient on or after March 1, 2021, with exposure to the implicated ultrasound gel product Healthcare facilities should also report any patient infections related to the use of potentially contaminated medical products to FDA’s MedWatch Adverse Event Reporting program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. As per the manufacturer of the MediChoice®M500812 ultrasound gel product, immediately destroy or return products from all affected lots AND stop use for all products under the brand names (more information attached). Devices and equipment that have been in contact with the implicated ultrasound gel products should be cleaned, disinfected, and reprocessed immediately before reuse with disinfectants under List B: EPA’s Registered Tuberculocide Products Effective Against Mycobacterium tuberculosis. CDC advises that healthcare facilities should 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 use of bottles of non-sterile ultrasound gel for visualization prior to such procedures (e.g., vein marking, visualizing ascites). Healthcare facilities should also review facility practices related to ultrasound probe reprocessing to ensure they are aligned with manufacturer’s instructions for use and appropriate professional society guidelines. Contact Information: • Gabriel Innes, Antimicrobial Resistance (AR) Surveillance Coordinator, NJDOH: Email: Gabriel.innes@doh.nj.gov • Jason Mehr, Hospital-associated Infection (HAI) Coordinator, NJDOH: Email: Jason.Mehr@doh.nj.gov • NJDOH Communicable Disease Service, (609) 826-5964 during business hours


This information has been broadcasted to: DHSS Senior Staff|DHSS Staff|LINCS Health Officers|LINCS Health Officer Assistants|LINCS Coordinators|LINCS Coordinator Backups|LINCS Epidemiologists|LINCS Health Educators|LINCS Health Planners|LINCS IT Specialists|LINCS Partnership Coordinators|LINCS Public Health Nurses|LINCS Regional Health Planners|LINCS Team Members|LINCS CD Investigators|LINCS REHS|LOCAL Health Officers|LOCAL Public Health|LOCAL CD Investigators|LOCAL Health Educators|LOCAL Public Health Nurses|LOCAL REHS|LOCAL Epidemiologists|Animal Health Organizations|Blood Banks|Community Health Centers (FQHCs)|DOH Program Staff|EMS Council|FQHC_1|FQHC_2|Health Care Organizations|Hospital Emerg Preparedness Coords|Hospital ER Medical Directors|Hospital Infection Control Practitioners|Hospital Medical Directors|Hospital Nursing Directors|Hospital Staff Directory|Hospitals / Veterans|Labs / Non-Sentinel|Labs / Sentinel|Occupational Health Organizations|Public Health Associations|Public Health Council