In response to questions from AHA and others and informed by testing results, the Food and Drug Administration April 21 announced that health care providers without alternative options may continue to use a certain version of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid barrier protection if they wear a face shield over the respirator. 

The agency April 12 announced () that health care providers and consumers should not use certain N95 respirators made by O&M Halyard because they do not meet quality and performance expectations, and should not use certain surgical masks and pediatric face masks made by the company for fluid barrier protection. FDA continues to evaluate quality and performance information for these products and will provide updates as more information becomes available. The agency said it also continues to work with providers to assist with challenges and can help them find alternative sources and products. 

Related News Articles

Headline
The Food and Drug Administration is evaluating Chinese-made plastic syringes used to inject or withdraw fluids from the body, citing concern that they may…
Headline
The Food and Drug Administration Nov. 9 cleared for marketing the Flowflex COVID-19 Antigen Home Test, the first COVID-19 antigen test and second COVID-19 at-…
Headline
The Department of Health and Human Services’ Administration for Strategic Preparedness and Response yesterday awarded $600 million for 12 domestic COVID-19…
Headline
Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath, which exceed acceptable levels if…
Headline
Crews are working to restore power and assess damage to a Pfizer plant in North Carolina that makes sterile injectables for U.S. hospitals after a tornado…
Headline
Federal agencies last month stopped over 500 unapproved pharmaceutical products and medical devices, including opioid and other controlled substances, from…