The California Department of Health has issued an All Facilities Letter (AFL) notifying healthcare facilities that a subset of model DE2322 N95 respirator units distributed by BYD Precision Manufacture Co., Ltd. do not meet the National Institute for Occupational Safety and Health (NIOSH) criteria. These nonconforming units should be returned to the manufacturer. The affected N95 masks have a slight decrease in particle filtration efficiency (PFE) below NIOSH's N95 PFE specification. Facilities should inspect their N95 respirator product boxes to identify affected units by checking the Lot # and Serial # on the tracking label. If both numbers match the information provided in the BYD Field Action Notification, the unit is considered nonconforming. BYD has established a dedicated team to assist customers with replacing affected units. Facilities can contact BYD's Customer Service team at 1-800-293-2886 or fieldaction@byd.com (Ref #: FA-0115) for questions, returns, and replacements.

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