FDA-Device2022-08-03Class II
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Davol, Inc.
Hazard
The device may potentially cause a fire, leading to a safety risk.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Affected count
9420 (9337 in US; 83 OUS)
Manufactured in
100 Crossings Blvd, Warwick, RI, United States
Products
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2022Don't want to check this manually?
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