Z-0728-2025 Class II Ongoing
FDA device recall Z-0728-2025 was initiated by O&M HALYARD, INC. on November 8, 2024 and is designated Class II. 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 p… The recall status is ongoing. Affected quantity: 211 cases.
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