FDA Enforcement
Class II
Ongoing
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Recall: Z-0728-2025
·
Reported January 1, 2025
Enforcement
- Recall Number
- Z-0728-2025
- Event ID
- 95804
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- O&M HALYARD, INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 1, 2025
- Initiation Date
- November 8, 2024
- Classification Date
- December 20, 2024
- Address
- 9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States
Description
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
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 Info
UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Distribution
Nationwide
Quantity
211 cases