FDAClass IIIFebruary 15, 2023

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT recall

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

Why was FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT recalled?

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.

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 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

Product
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Recalling firm
Owens & Minor Distribution, Inc.
Quantity
73 cases
Distribution
US distribution to IL, NC, NY, OH, and PA.
Recall date
February 15, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls