Updated User Instructions for Three NIOSH-Approved Filtering Facepiece Respirators
Updated user instructions for three NIOSH-approved filtering facepiece respirators ( TC-84A-9298, TC-84A-9308, and TC-84A-9315 )
"NIOSH identified a statement about shortening headbands by knotting in the user instructions (UI) of three N95 approvals, recently issued to BNX Converting, LLC (BNX). The instruction to shorten the headbands by knotting is not in agreement with the NIOSH Caution and Limitation N - Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as specified by the manufacturer.
A limited number of respirators were distributed with UIs that include this instruction. BNX was informed about the concern and took immediate action to remove the problematic statement from the UIs. This notice is intended to notify users that if they cannot achieve a fit, the respirator should not be modified in any way to achieve a satisfactory fit.
For more information, view the NIOSH Conformity Assessment Letter to Manufacturers (CA 2021-1037).