O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Reported: January 1, 2025 Initiated: November 8, 2024 #Z-0728-2025
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.
Details
- Recalling Firm
- O&M HALYARD, INC.
- Units Affected
- 211 cases
- Distribution
- Nationwide
- Location
- Mechanicsville, VA
Frequently Asked Questions
What product was recalled? ▼
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117. Recalled by O&M HALYARD, INC.. Units affected: 211 cases.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0728-2025.
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