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Recall Observatory FDA recall evidence

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

May 21, 2021

Class II

Product summary

Firm
Sunstar Americas, Inc.
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

    reason.microbial_contamination · v1.0.0

    contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia