The FDA updated its usage recommendations for a surgical N95 respirator manufactured by O&M Halyard April 21. The respirator is one of several masks and respirators the agency flagged quality concerns about earlier this month.
Healthcare workers without alternative options may still use the orange fluidshield level 3 surgical N95 respirator mask (model number 46727) for fluid barrier protection if they accompany it with a face shield, the FDA said April 21. The agency said it issued the clarification in response to questions from healthcare organizations.
The update comes about two weeks after the agency first issued a warning about several O&M Halyard respirators and masks, citing lab results showing some products do not meet quality and performance standards.
"This is an evolving situation, and we will continue to keep the public informed as new or additional information becomes available about these and other O&M surgical N95 respirators," the agency said.
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