FDA-Device2016-12-21Class II
Cellfina Prep Pack, Part No. CP1
Ulthera Inc
Hazard
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
Sold states
Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
Affected count
6562 units
Manufactured in
1840 S Stapley Dr Ste 200, Mesa, AZ, United States
Products
Cellfina Prep Pack, Part No. CP1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0749-2017Don't want to check this manually?
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