Sunstar Americas, Inc. Recall 87976
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.
Sunstar Americas, Inc. Recall 87976 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1837-2021 |
| Event ID | 87976 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Mexico. |
| Quantity | 124064 units |
| Recall Reason | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. |
| Device Classification | 20210616 |
| Device Code Info | 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 |
| Center Classification Date | 20210609 |
| Recall Initiation Date | 20210521 |
| Recalling Firm | Sunstar Americas, Inc. |
| Initial Notification | Letter |
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