United States
Company name: Eco-Med Pharmaceutical
Brand name: Multiple brand names
Product recalled: Ultrasound Gel
Reason of the recall: Product is contaminated with bacteria (Burkholderia cepacia complex)
FDA Recall date: August 04, 2021
Recall details: Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures. 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. Affected product lot numbers are below:
- Product: Eco Gel 200 MediChoice M500812
- Lot Numbers and Initial Distribution Date:
B029 March 26, 2021
B030 March 30, 2021
B031 April 5, 2021
B032 April 7, 2021
B040 April 26, 2021
B041 April 26, 2021
B048 May 7, 2021
B055 May 26, 2021
Additionally, 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)
Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.
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. 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.
Check the full recall details on
www.fda.gov
Source: FDA
