Recall Z-1837-2021— Sunstar Americas, Inc.

Name: FDA recall Z-1837-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-21

Class II · Terminated

Class II FDA medical device recall by Sunstar Americas, Inc., initiated 2021-05-21, terminated 2024-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.. Reason: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans..

Recalling firm: Sunstar Americas, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-21
Terminated: 2024-09-04
Firm location: Schaumburg, IL, United States

Product description

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

Reason for recall

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

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