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Ulthera Inc recalls Cellfina Prep Pack, Part No. CP1
Recalled December 21, 2016 · FDA recall Z-0749-2017 · Ulthera
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. · FDA Class II
Units
6562 units
Sold at
Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
Description
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.
Product
Cellfina Prep Pack, Part No. CP1
Manufacturer(s)
Ulthera Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →