Recall Z-0749-2017 ยท OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Ulthera Inc
Cellfina Prep Pack, Part No. CP1
| Date | Dec 13, 2016 (initiated Nov 14, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter inform |
| Quantity | 6562 units |
| Distribution | Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161885 | The Cellfina System Ulthera, Inc., Oct 5, 2016 |