April 25, 2023

FDA updates Safety Communication on Halyard surgical N95 respirators

By: Judy Mathias
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Editor's Note

In response to questions, on April 21, the Food and Drug Administration (FDA) provided an update to its Safety Communication that enables the use of existing inventory of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Regular), Level 3, (Model 46727).

The FDA recommends that, if necessary, this model may continue to be used:

  • in nonsurgical settings when fluid barrier protection against splashes, sprays, or splatter is not needed
  • in surgical settings, if a face shield is worn over the N95 respirator mask.

The FDA continues to recommend that the FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Small), Level 3, (Model 46827) not be used.

The FDA says it will continue to keep the public informed as new or additional information becomes available.

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