FDA provides update on O&M Halyard surgical N95 respirators and use of existing inventory
On August 9, 2023, O&M Halyard sent a recall notice instructing customers not to use lot #AM2164811 of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827), because this respirator may not provide adequate filtration protection to the user. This recall is a product removal of the one affected lot. Contact O&M Halyard if you have any questions about the recall or did not receive their notice at [email protected] using the Event # FA-2023-011 in the subject line.
For all other lots of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827), the FDA recommendations are the same as the FDA recommendations provided on April 21, 2023, for the FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3, (Model 46727), and are as follows:
- 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:
- 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.
Unique Device Identifier (UDI) information provided by O&M Halyard:
- FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827): 20680651468271
- FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3, (Model 46727): 20680651467274
The FDA continues to evaluate fluid resistance concerns identified through laboratory testing for both O&M Halyard surgical N95 respirators. This continues to be an evolving situation, and we will continue to keep the public informed about these surgical N95 respirators.
FDA recommendations provided on April 12, 2023, for certain O&M Halyard surgical masks (including procedure masks) and pediatric face masks have not changed. The FDA continues to work with the manufacturer to evaluate testing results and will continue to keep the public informed about the masks.
