Face Masks Packaged in Incorrect Dispenser Boxes with Mismatched Labeling
73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The issue is incorrect dispenser box labeling that does not match the mask design. This is a documentation and packaging problem without reported harm, meeting the criteria for Score 1.
Plain-English summary
Owens & Minor Distribution, Inc. is recalling 73 cases of FLUIDSHIELD 3 Fog-Free Procedure Masks with SO SOFT Lining and SO SOFT Earloops (Product Code 47147, Lot AM2222041, Expiration Date 2027-08-10).
The face masks were placed into dispenser boxes that are incorrectly labeled. The dispenser boxes are labeled as containing masks with ties, but the actual masks inside have ear loops instead. This mismatch between the actual product and its packaging label could cause confusion about proper mask usage.
The affected products were distributed to Illinois, North Carolina, New York, Ohio, and Pennsylvania.
The recalled product
- Product
- FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- Manufacturer
- Owens & Minor Distribution, Inc.
- Category
- Medical Device — Procedure Mask
- Hazard
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Distribution
Distributed in 5 states:
- IL
- NC
- NY
- OH
- PA
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