HomeLatest NewsFederal NewsFDA Issues Update on Ventilator Recall

FDA Issues Update on Ventilator Recall

The Food and Drug Administration (FDA) last week issued an update on the Class 1 recall of certain Philips Respironics ventilators. According to the update, FDA has asked the company to retain an independent laboratory to determine whether an incorrect silicone-based foam used to repair and replace certain recalled Trilogy Evo ventilators poses a risk to patient safety. Meanwhile, FDA does not recommend that patients who participated in the repair and replace program discontinue use of the product.

In other news, FDA last week named four active pharmaceutical ingredients to a list of compounding ingredients for which 503B outsourcing facilities may qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act due to critical need.

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