Wednesday, August 18, 2021

Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers

Ultrasound gels and lotions manufactured by Eco-Med may be contaminated with bacteria.

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FDA - Center for Devices and Radiological Health

Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to inform health care providers, health care facility risk managers, and procurement staff to immediately stop use of and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc).

EcoGel ultrasound gel products and lotions manufactured by Eco-Med are distributed by a number of companies under various product names, including MediChoice Ultrasound Gel distributed by both Owens & Minor and Mac Medical Supply Co., Inc.  

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The Letter to Health Care Providers includes important information about Eco-Med ultrasound gels and lotions, including:

  • The specific names of affected products
  • Details on Eco-Med ultrasound gel and lotion contamination.
  • Recommendations for health care providers and facilities.
  • Actions the FDA is taking to address the issue.
  • Instructions for reporting problems with Eco-Med ultrasound gel and lotion products.

Questions?

If you have questions about this product, contact the Division of Industry and Consumer Education (DICE).


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