Device 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.
Z-1837-2021
Product summary
- Event
- Event 87976
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124064 units
- Official record key
device-enforcement:Z-1837-2021
Official wording
Reason: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
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
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Mexico.
Derived failure modes
-
Microbial contamination
contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia