Cellfina Prep Pack, Part No. CP1
FDA device recall Z-0749-2017 · posted 2016-12-13 · Terminated
Recall details
- Recalling firm
- Ulthera Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- OUP
- Quantity affected
- 6562 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
- Date initiated
- 2016-11-14
- Date posted
- 2016-12-13
- Date terminated
- 2017-09-13
- Location
- Mesa, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| The Cellfina System (K161885) | Ulthera, Inc. | 2016-10-05 |