The Food and Drug Administration 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.
 
 

Related News Articles

Headline
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to…
Headline
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition…
Headline
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-…
Headline
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been…
Headline
The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a…
Headline
Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25…