Earlier today, we were notified that the FDA issued a recommendation that healthcare providers and facilities stop using the following O&M Halyard N95 respirators:

• Fluidshield Surgical N95 Respirator Mask, Orange (Regular), Level 3 – Model # 46727
• Fluidshield Surgical N95 Respirator Mask, Orange (Small), Level 3 – Model $46827

Even though O&M Halyard has not initiated a recall of these masks at this time and is conducting additional testing analysis, in line with the FDA’s guidance, we are asking that anyone currently wearing these masks stop wearing them immediately. We are also asking leaders to please remove any masks from the floors/areas where they are stored for us and return them to the Materials Management Department at your site or, for those sites without a Materials Management Department, please send them via courier to the Service Center.

While we work to identify an alternative mask and complete the fit testing process for that alternative mask, please take the following action if you are currently using one of the above masks: Work with your leadership to ensure you are not caring for anyone requiring respiratory isolation (ex: COVID-19) unless you are able to wear a PAPR.

We will continue to monitor this issue for further updates from the FDA and/or O&M Halyard. If you have experienced issues with the quality or performance of the above respirators, please contact Employee Health. Additionally, the FDA is asking users to report any issues here: MedWatch Online Voluntary Reporting Form (fda.gov)

Thank you for all that you do to care for our patients, each other, and the communities we serve.