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Recall Observatory FDA recall evidence

Device product

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

Z-1059-2023

January 03, 2023

Class III

Product summary

Firm
Owens & Minor Distribution, Inc.
Event
Event 91530
Status
Ongoing
Classification
Class III
Quantity
73 cases
Official record key
device-enforcement:Z-1059-2023

Official wording

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 with ties instead of ear loops.

Code information: UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

Distribution pattern: US distribution to IL, NC, NY, OH, and PA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled

Field note

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