Recall Z-1182-2021— Sunstar Americas, Inc.

Name: FDA recall Z-1182-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-18

Class II · Terminated

Class II FDA medical device recall by Sunstar Americas, Inc., initiated 2021-02-18, terminated 2024-09-30. It names one FDA 510(k) clearance: K181134. 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.. Reason: The product may be contaminated with Burkholderia cepacia.

Recalling firm: Sunstar Americas, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-18
Terminated: 2024-09-30
Firm location: Schaumburg, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K181134 — GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc.·cleared 2018-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The product may be contaminated with Burkholderia cepacia

Data sourced from openFDA. This site is unofficial and independent of the FDA.