FDA Device recall Z-0749-2017
Cellfina Prep Pack, Part No. CP1
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of Cellfina Prep Pack, Part No. CP1 by Ulthera, citing 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 proc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0749-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-14 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ulthera |
| Distribution | n/a |
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.
Identifiers
| code_info | all |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.