Class 2 Device Recall GUM PerioShield

• Date Initiated by Firm: May 21, 2021
• Create Date: June 09, 2021
• Recall Status: Terminated on September 04, 2024
• 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
• FEI Number: 1413787
• 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: 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.