Medical device recalls Moderate risk

Sunstar Americas, Inc. recalls SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gi…

Recall date
May 21, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1837-2021
FDA classification
Class II
Brand / firm
Sunstar Americas, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution and the country of Mexico.

Why it was recalled

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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