FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
FDA Recall Z-1059-2023 · Posted 2023-02-03
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Recalling FirmOwens & Minor Distribution, Inc.
Recall StatusOpen, Classified
Product CodeFXX
Date Initiated2023-01-03
Product Quantity73 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.
Firm Action
On January 3, 2023, the firm notified affected distributors via email with a "VOLUNTARY FIELD CORRECTION" letter.
Consignees are instructed to immediately stop use of the product, quarantine any stock and destroy all the product using the facility s standard disposal procedure. Consignees are requested to complete and return a Recall FIELD CORRECTION RESPONSE FORM and a Certificate of Destruction.
If you have any questions, please email Anu Singh @ [email protected] using the Event # FCA-2022-012 in the header of the response.
Root Cause
Labeling Change Control
Distribution Pattern
US distribution to IL, NC, NY, OH, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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