This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.
viewpoints
Welcome to Reed Smith's viewpoints — timely commentary from our lawyers on topics relevant to your business and wider industry. Browse to see the latest news and subscribe to receive updates on topics that matter to you, directly to your mailbox.
| less than a minute read

FDA announces product recall for certain batches of ultrasound gel

The Food and Drug Administration (FDA) has published a recall notice from Eco-Med Pharmaceuticals, Inc., a Canadian company, for certain lots of the company's Eco-Gel 200 ultrasound gel, after fifteen people were reported to have a bacterial infection after its use. According to the company's news release, the gel may be contaminated with Burkholderia cepacia complex (Bcc).

The product is also distributed under the name of MediChoice Ultrasound Gel. 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.

in 2019, the FDA released final guidance for industry and FDA staff entitled “Public Warning and Notification of Recalls." The FDA guidance describes the use, content, and circumstances for issuance of public warnings and public notification of recalls under federal regulations. The FDA's intent is to "increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about products being recalled."

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Tags

health care & life sciences, fda, recall notice, diagnostic imaging, ultrasound

Latest Insights

post featured image
post featured image