The FDA is recommending that the following respirators manufactured by Halyard should not be used at the present time due to concerns over quality and performance expectations and may not provide the expected fluid barrier protection to the wearer:
46727 (or 76727) FLUIDSHIELD Surgical N95 Respirator Mask, Regular (Medium) and 46827 FLUIDSHIELD Surgical N95 Respirator Mask, Small (“Duckbill” N95’s).
Please note that the filtering capacity of these masks (e.g. for use in TB isolation) was NOT reported to be compromised. We will be removing these products from our inventory and from the units until we receive further information from the FDA and the manufacturer.
We currently have an ample supply of Moldex and 3M N95s, which are not affected.
If you have only been fit-tested to wear a small or regular Halyard N-95, you will need to be re-fit-tested for one of the other respirators. Fit testing is performed every Tuesday in April from 7 a.m. to 11 a.m. and every Tuesday and Thursday in May from 7 a.m. to 11 a.m. in the Kelemen building, 2nd Floor, Conference Room B (Cafeteria B). Additional scheduled hours for fit-testing can be found here.
If you have any questions about the removal of these products, please contact our Vice-President of Supply Chain, Tom Runkle, at Runkle-Thomas@cooperhealth.edu