Z-0749-2017 Class II Terminated
FDA device recall Z-0749-2017 was initiated by Ulthera Inc on November 14, 2016 and is designated Class II. 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. The recall status is terminated (terminated September 13, 2017). Affected quantity: 6562 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- November 14, 2016
- Termination Date
- September 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6562 units
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.
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
Code Information
all