FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 20680651468271; Lot Number AM2164811
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- O&M HALYARD, INC.
- Reason for Recall:
- One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Product Codes/Lot Numbers:
UDI-DI: 20680651468271; Lot Number AM2164811
Distribution:
Distributed in: US, FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2626-2023
Related Recalls
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
O&M HALYARD
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
O&M HALYARD
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.