BEUDAMED
    FDA Recall Open, Classified

    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

    Recall: Z-2626-2023 · Initiated August 9, 2023

    Recall

    Recall Number
    Z-2626-2023
    Event Number
    92942
    Firm
    O & M HALYARD, INC.
    FEI Number
    3014527898
    Product Code
    MSH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 9, 2023
    Posted
    September 21, 2023
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015

    Description

    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

    Reason

    One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

    Action

    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 [email protected] 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 [email protected]. 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 @ [email protected] using the Event # FA-2023-011 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc. team.

    Distribution

    US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia

    Quantity

    41790 masks