Special Alerts

On 12 Apr 2023, the United States Food and Drug Administration (FDA) alerted the users and public that certain O&M Halyard surgical respirators, surgical masks (including procedure masks), and pediatric face masks have failed fluid resistance performance tests at the expected protection level. FDA recommended consumers, health care providers, and facilities not to use these surgical N95 respirators and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard.

According to the FDA following surgical N95 respirators by O&M Halyard are affected:

• FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3 [Model Number: 46727]
• FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3 [Model Number: 46827]

Medical Device Division (MDD) has already uploaded the related communication to MDD’s website on 13 Apr 2023.

On 21 Apr 2023, the FDA is providing an update to its recommendations that enable use of existing inventory of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Regular), Level 3, (Model 46727).

• If necessary, this model may continue to be used for respiratory protection when fluid barrier protection against splashes, sprays, or splatter is not needed, such as in non-surgical settings where exposure to liquid, bodily or other hazardous fluids is not expected.
• When fluid barrier protection against splashes, sprays, or splatter is needed, such as in surgical settings where exposure to liquid, bodily or other hazardous fluids may occur:
  • Users should consider alternative options and seek an alternative surgical N95 respirator, if possible.
  • In the absence of alternative options, the risk of fluid exposure can be mitigated by wearing a face shield over the respirator to prevent fluid penetration.

The FDA continues to recommend that the FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827) by O&M Halyard not be used due to concerns with particulate filtration and fluid resistance identified through laboratory testing.

The FDA is continuing its evaluation.

For further information, please visit https://www.fda.gov/medical-devices/safety-communications/risk-protection-failure-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 May 2023