O&M HALYARD, INC. recalls O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable sur
Recalled Product
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Hazard / Issue
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Issued by
FDA
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