Cellfina Prep Pack recalled over sterility concerns

Recall date

November 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ulthera Inc recalls Cellfina Prep Pack, Part No. CP1

Recall number

Z-0749-2017

FDA classification

Class II

Brand / firm

Ulthera Inc

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)

Why it was recalled

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.

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

What was recalled

Cellfina Prep Pack, Part No. CP1