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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 Earloops see related information
Date Initiated by Firm January 03, 2023
Date Posted February 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-1059-2023
Recall Event ID 91530
510(K)Number K131879  
Product Classification Mask, surgical - Product Code FXX
Product FLUIDSHIELD 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 Contact Anu 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
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 @ OMRA_RECALLS@owens-minor.com using the Event # FCA-2022-012 in the header of the response.
Quantity in Commerce 73 cases
Distribution US distribution to IL, NC, NY, OH, and PA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FXX and Original Applicant = KIMBERLY-CLARK CORP.
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