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U.S. Department of Health and Human Services

Class 2 Device Recall GUM PerioShield

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  Class 2 Device Recall GUM PerioShield see related information
Date Initiated by Firm May 21, 2021
Create Date June 09, 2021
Recall Status1 Completed
Recall Number Z-1837-2021
Recall Event ID 87976
Product Classification Rinse, oral, antibacterial (by physical means) - Product Code NTO
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.
Code Information SKU number 1775P, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B SKU number 1775R, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B
Recalling Firm/
Manufacturer		 Sunstar Americas, Inc.
301 E Central Rd
Schaumburg IL 60195-1901
Manufacturer Reason
for Recall		 Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by letter on 05/21/2021. The firm is requesting the return of the product and has directed the distributors to notify their customers.
Quantity in Commerce 124064 units
Distribution Worldwide distribution - US Nationwide distribution and the country of Mexico.
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.
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