PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 16, 2021 Initiated: May 21, 2021 #Z-1837-2021

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.

Details

Recalling Firm
Sunstar Americas, Inc.
Units Affected
124064 units
Distribution
Worldwide distribution - US Nationwide distribution and the country of Mexico.
Location
Schaumburg, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sunstar Americas, Inc.. Units affected: 124064 units.
Why was this product recalled?
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 16, 2021. Severity: Moderate. Recall number: Z-1837-2021.