FDA MedWatch - Eco-Gel 200 by Eco-Med Pharmaceutical: Recall

Due to Bacterial Contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Eco-Gel 200 by Eco-Med Pharmaceutical: Recall - Due to Bacterial Contamination AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Eco-Med Pharmaceuticals initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). The effects of the bacteria, Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc), vary widely, ranging from no symptoms at all to serious infections.  Bcc bloodstream infections may result in sepsis and in certain cases, potentially death. Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections.  Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing.  For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The ultrasound gels are non-sterile and not indicated for sterile procedures.  Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.   RECOMMENDATIONS:  Eco-Med is instructing all health care facilities to identify the affected products, Eco Gel 200 or MediChoice M500812, by lot number (B029, B030, B031, B032, B040, B041, B048 and B055) and immediately destroy or return products from affected lots to Eco-Med. Eco-Med is instructing all health care facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under these brand names in these geographies: EcoGel 200, by Eco-Med (Canada) MediChoice Ultrasound Gel, by Owens & Minor (United States) MediChoice Ultrasound Gel, by Mac Medical Supply Co Inc. (United States) EcoGel 200, by Active Crystal Inc (Canada) EcoGel 200, by Agencia Matamoros (Honduras) EcoGel 200, by Cardinal Health Canada EcoGel 200, by CMCC Supply Centre and Bookstore (Canada) EcoGel 200 Blue, by Christie Innomed Inc. (Canada) EcoGel 200, by Dectro International (Canada) EcoGel 200, by Medline Canada EcoGel 200, by Dunbar Medical (Canada) EcoGel 200, by Eastern Medical Supply Ltd (Canada) EcoGel 200, by Global Medical Solution (NZ) LTD (New Zealand) EcoGel 200, by Good-link Electronics Ltd. (Hong Kong) EcoGel 200, by Henry Schein Arcona (Canada) EcoGel 200, by Maranda Lauzon Inc (Canada) EcoGel 200, by Medi's Part Ltd. (Thailand) EcoGel 200 Blue, by MJM Distributing (Canada) EcoGel 200, by Ortho Canada (Canada) EcoGel 200, by So medico SDN BHD (Malaysia) EcoGel 200 and EcoGel 200 Blue, by STAT Healthcare Corporation (Canada) EcoGel 200 and EcoGel 200 Blue, by The Stevens Company Limited (Canada) EcoGel 200, by Strathroy Middlesex General Hospital (Canada) EcoGel 200, by Trimedic Supply Network Ltd. (Canada) EcoGel 200, by Vitality Depot (Canada) Chattanooga Conductor USA, by DJO Global (United States) Conductor Australia, by DJO Australia DJO Conductor, by DJO Global (United States)  Liquasonic, by Athena Medical Products Inc. (United States) Medico, by Medico Inc. (Canada) Medline, by Medline Industries Inc. (United States) NDC Eco-Gel 200 Ultrasound Gel, by NDC Inc. (United States) Omni, by Accelerated Care Plus Leasing Inc. (United States) Red Medical Ultrasound Gel Blue, by Red Medical Supplies Ltd. (Canada) Smart 200, by Smart Technology and Product Co., Ltd (Thailand) Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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