FDA Medical Device Recalls (openFDA)
Ulthera Inc: Cellfina Prep Pack, Part No. CP1
- Recall number
- Z-0749-2017
- Recalling firm
- Ulthera Inc
- Product
- Cellfina Prep Pack, Part No. CP1
- Status
- Terminated
- Initiated
- 2016-11-14
- Posted
- 2016-12-13
- Terminated
- 2017-09-13
- 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 informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.
- Quantity
- 6562 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
- Lot, serial or model codes
- all
- 510(k) numbers
- ["K161885"]
- PMA numbers
- not on file
- Product code
- OUP
- Firm FEI
- 1012187
- Firm city
- Mesa
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28