Recall Z-0749-2017— Ulthera Inc

Name: FDA recall Z-0749-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-14

Class II · Terminated

Class II FDA medical device recall by Ulthera Inc, initiated 2016-11-14, terminated 2017-09-13. It names one FDA 510(k) clearance: K161885. Product: Cellfina Prep Pack, Part No. CP1. Reason: 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..

Recalling firm: Ulthera Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-14
Terminated: 2017-09-13
Firm location: Mesa, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K161885 — The Cellfina SystemUlthera, Inc.·cleared 2016-10-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cellfina Prep Pack, Part No. CP1

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.