FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
This recall is currently active, issued September 21, 2023. It was issued by O & M Halyard, Inc..
- Company
- O & M Halyard, Inc.
- Recall Initiated
- August 9, 2023
- Posted
- September 21, 2023
- Recall Number
- Z-2626-2023
- Quantity
- 41790 masks
- Firm Location
- Mechanicsville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Distribution
US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
Lot / Code Info
UDI-DI: 20680651468271; Lot Number AM2164811
Root Cause
Under Investigation by firm
Action Taken
An "URGENT: PRODUCT FIELD ACTION" dated 8/9/23 was sent to customers. The letter described the product, the problem and actions to take. The customers were instructed to do the following: If you received the lot identified above, please review your inventory, and segregate and quarantine all affected product. All other codes and lots of this product are NOT impacted by this Field Action. Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 2. SEGREGATE AND QUARANTINE all product on-hand per the Affected Product table above. 3. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 4. COMMUNICATE this Field Action to staff to ensure awareness of it. 5. RETURN the completed Field Action Response Form and Certificate of Destruction Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 6. Any adverse events associated with the use of the affected product should be reported to PIQ@hyh.com. 7. If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, please email Anu Singh @ OMRA_RECALLS@owens-minor.com using the Event # FA-2023-011 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc. team.