Z-0728-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 cases
Product Description
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18