FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code
Summary
The FDA issued a Class II for FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* by O&M HALYARD, INC.. Reason: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user..
Details
Source
Device Recall
External ID
Z-2626-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Lot/Code Info: UDI-DI: 20680651468271; Lot Number AM2164811
Quantity Affected: 41790 masks
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-09
Company
Mechanicsville, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (O&M HALYARD, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD, INC. have FDA actions?
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2626-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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