Recall Z-0729-2025 ยท FXX Mask, Surgical
O&M HALYARD, INC.
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
| Date | Dec 20, 2024 (initiated Nov 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | O&M Halyard issued Urgent: Product Field Action via email on 11/8/24 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 2. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 3. COMMUNICATE this Field Action to staff to ensure awareness of it. 4. RETURN the completed Field Action Response Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 5. Any adverse |
| Quantity | 637 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |