Product Communications
UPDATED: Recommendations for Consumers, Healthcare Providers and Facilities Regarding Certain Surgical N95 Respirators by O&M Halyard
We are pleased to notify customers that O&M Halyard is now resuming sales and shipments of the HALYARD* N95 product codes listed in the table below.
Users may now disregard previous recommendations to wear a face shield in addition to a HALYARD* N95 respirator for fluid barrier protection against splashes, sprays, or splatter.
This update is the result of extensive testing and performance data reviewed by NIOSH and FDA demonstrating that HALYARD* N95 surgical respirators continue to provide the rated levels of particle filtration and fluid resistance.
This update applies to the N95 models listed in the table below:
| Model Name | Model Number | NIOSH Approval # TC - |
|---|---|---|
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask, Orange, with SO SOFT* Lining, Regular Size | 46727 | 84A-7521 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask, Orange, with SO SOFT* Lining, Small Size | 46827 | 84A-7518 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Regular Size | 46767 | 84A-7523 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Small Size | 46867 | 84A-7520 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask, Orange, with SO SOFT* Lining, Regular Size | 76727 | 84A-7521 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask, Orange, with SO SOFT* Lining, Small Size | 76827 | 84A-7518 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Regular Size | 76767 | 84A-7523 |
| FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Small Size | 76867 | 84A-7520 |
As a leading supplier of facial protection, we know that thousands of U.S. healthcare facilities rely on Owens & Minor’s HALYARD* brand each day for products that help ensure clinician and patient safety. We value your ongoing partnership and look forward to continuing to serve your facial protection needs. Please contact your O&M Halyard account manager for questions or assistance.
Voluntary Recall of Lot #AM2164811
On August 9, 2023, O&M Halyard initiated a voluntary recall of one lot of N95s for particle filtration test failures. While we have not received any complaints or reports related to filtration for this lot, the information below provides guidance on actions that users in possession of product from this lot are advised to perform. Our internal testing indicates that other shipped lots of this product code provide the expected level of filtration. This information is unchanged from our previous customer communication and does not identify a new issue or lot of concern.
| Model | Lot Numbers |
|---|---|
| 46827 | AM2164811 |
The lot number can be found on the label of the product codes depicted below:
- Check your supply of surgical N95 respirators to determine if you have the affected lot of the model listed above.
- Do not use respirators from lot AM2164811 listed in of product code 4682780.
- Report any issues with the quality or performance of respirators to O&M Halyard Customer Service at [email protected] or call 1-877-425-9273 or the FDA.