Ulthera Inc: Medical Device Recall in 2016 - (Recall #: Z-0749-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Cellfina Prep Pack, Part No. CP1

Product Classification:

Class II

Date Initiated: November 14, 2016

Date Posted: December 21, 2016

Recall Number: Z-0749-2017

Event ID: 75682

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6562 units

Code Information:

all

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated