Eco-Med Ultrasound Lotions Gels and Lotions Recalled Due to Burkholderia cepacia complex (Bcc) Bacteria Contamination Risk On 09/28/2021, the U.S. Food and Drug Administration (“FDA”) and Eco-Med Pharmaceutical, Incorporated announced a Class I recall of all Eco-Med Ultrasound Lotions Gels and Lotions. An FDA Class I recall is the most severe type of product recall. Products categorized as […]
Eco-Med Ultrasound Lotions Gel Recalls
On 09/28/2021, the U.S. Food and Drug Administration (“FDA”) and Eco-Med Pharmaceutical, Incorporated announced a Class I recall of all Eco-Med Ultrasound Lotions Gels and Lotions. An FDA Class I recall is the most severe type of product recall. Products categorized as a Class I recall may cause injury or death. Eco-Med’s ultrasound gels and lotions are rebranded and resold under several other companies and brands names, including and are not limited to:
Eco-Med’s affected ultrasound gels and lotions are applied to the skin and/or ultrasound device to create electronic images of fetuses, organs, and other structures located inside the patient’s body when conducting an ultrasound test. Ultrasound gels and lotions are transparent, water-based gels that help transmits sound waves resulting in an image.
The affected ultrasound gels and lotions that Eco-Med has manufactured are recalled due to potential Burkholderia cepacia complex (Bcc) bacterial contamination. The FDA has also independently verified that distributed products have tested positive for Burkholderia cepacia bacterial contamination. Using the recalled ultrasound lotions and gels that are contaminated with Burkholderia cepacia could cause serious infections. These infections may include bloodstream infections, resulting in sepsis or death.
There have been 60 bloodstream infections connected with the recalled Eco-Med ultrasound products, the Centers for Disease Control and Prevention (CDC) reported.
Eco-Med Pharmaceutical, Incorporated issued a recall classification notice for some lots of EcoGel, MediChoice, and the company’s Mac Medical ultrasound gel. The FDA has decided that all Eco-Med ultrasound gels and lotions must be recalled due to the Burkholderia cepacia complex (Bcc) risk.
The FDA also urges ultrasound patients, health care providers, and facilities to:
Eco-Med has closed down all of its operations and is not distributing or manufacturing any products.
Who Could Be Affected?
Ultrasound technicians and healthcare providers use ultrasound lotions and gel made by Eco-Med Pharmaceutical, Inc., and distributed by one of its several entities under various brand names.
Patients who receive an ultrasound that uses ultrasound lotions or gels manufactured by Eco-Med Pharmaceutical and distributed by one of the previously mentioned entities.
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