The Food and Drug Administration (FDA), on April 12, issued a Safety Communication recommending that consumers, healthcare providers, and facilities not use certain surgical N95 respirators and to use caution with certain surgical masks and pediatric face masks, all manufactured by O&M Halyard.
The FDA says it is aware of laboratory test results showing that certain models do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer.
A full list of the affected masks are available in the Safety Communication. The FDA is continuing its evaluation.
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