Device 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.
Z-1182-2021
Product summary
- Event
- Event 87371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56960 bottles
- Official record key
device-enforcement:Z-1182-2021
Official wording
Reason: The product may be contaminated with Burkholderia cepacia
Code information: All lot codes within expiry
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
contaminated with Burkholderia cepacia