FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code
Summary
The FDA issued a Class III for FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, by Owens & Minor Distribution, Inc.. Reason: Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks .
Details
Source
Device Recall
External ID
Z-1059-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Lot/Code Info: UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Quantity Affected: 73 cases
Reason for Recall
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
Distribution
US distribution to IL, NC, NY, OH, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-03
Company
Mechanicsville, VA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Owens & Minor Distribution, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Owens & Minor Distribution, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Owens & Minor Distribution, Inc. have FDA actions?
Owens & Minor Distribution, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1059-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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