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U.S. Department of Health and Human Services

Class 2 Device Recall G.U.M. HYDRAL DRY MOUTH RELIEF

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  Class 2 Device Recall G.U.M. HYDRAL DRY MOUTH RELIEF see related information
Date Initiated by Firm February 18, 2021
Create Date March 05, 2021
Recall Status1 Open3, Classified
Recall Number Z-1182-2021
Recall Event ID 87371
510(K)Number K181134  
Product Classification Saliva, artificial - Product Code LFD
Product SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.
Code Information All lot codes within expiry
Recalling Firm/
Manufacturer		 Sunstar Americas, Inc.
301 E Central Rd
Schaumburg IL 60195-1901
Manufacturer Reason
for Recall		 The product may be contaminated with Burkholderia cepacia
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter and public notice on 02/18/2021. The letter stated that hazard and requested the return of the product.
Quantity in Commerce 56960 bottles
Distribution US Nationwide distribution.
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 = LFD and Original Applicant = Sunstar Americas Inc
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