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U.S. Department of Health and Human Services

Class 3 Device Recall FLUIDSHIELD 3 FogFree Procedure Mask with SO SOFT Lining and SO SOFT Earloops

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 Class 3 Device Recall FLUIDSHIELD 3 FogFree Procedure Mask with SO SOFT Lining and SO SOFT Earloopssee related information
Date Initiated by FirmJanuary 03, 2023
Date PostedFebruary 03, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1059-2023
Recall Event ID 91530
510(K)NumberK131879 
Product Classification Mask, surgical - Product Code FXX
ProductFLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Code Information UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Recalling Firm/
Manufacturer		 Owens & Minor Distribution, Inc.
9120 Lockwood Blvd
Mechanicsville VA 23116-2015
For Additional Information ContactAnu Singh
804-723-7000
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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 @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-012 in the header of the response.
Quantity in Commerce73 cases
DistributionUS distribution to IL, NC, NY, OH, and PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FXX
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