FDA recall Z-1457-2022

Davol, Inc. · Class II · device

Product

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

Reason for recall

The device may potentially cause a fire, leading to a safety risk.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

Key facts

Status
Ongoing
Initiation date
2022-06-27
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warwick, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2022