Z-1837-2021 Class II Terminated
FDA device recall Z-1837-2021 was initiated by Sunstar Americas, Inc. on May 21, 2021 and is designated Class II. Reason for recall: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. The recall status is terminated (terminated September 4, 2024). Affected quantity: 124064 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- May 21, 2021
- Termination Date
- September 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124064 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Mexico.
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