Recall Z-1837-2021 ยท NTO Rinse, Oral, Antibacterial (By Physical Means)
Sunstar Americas, Inc.
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.
| Date | May 21, 2021 |
| Status | Terminated |
| Reason | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. |
| Root 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 | 124064 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.