Fluidshield 3 N95 recall
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Why was Fluidshield 3 N95 recalled?
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 20680651468271; Lot Number AM2164811
- Product
- FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
- Recalling firm
- O&M HALYARD, INC.
- Quantity
- 41790 masks
- Distribution
- US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
- Recall date
- September 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)