Device product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Z-0728-2025
Product summary
- Event
- Event 95804
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 211 cases
- Official record key
device-enforcement:Z-0728-2025
Official wording
Reason: 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.
Code information: UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.