FDA MedWatch - Certain N95 Respirators by Shanghai Dasheng:

Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Certain N95 Respirators by Shanghai Dasheng: Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers Today, the U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng) because the firm did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval. The Letter to Health Care Providers includes recommendations and instructions for reporting problems.  Questions?  If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).

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