Cellfina Prep Pack recall: Sterility Concern
Cellfina Prep Pack, Part No. CP1
Why was Cellfina Prep Pack recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all
- Product
- Cellfina Prep Pack, Part No. CP1
- Recalling firm
- Ulthera Inc
- Quantity
- 6562 units
- Distribution
- Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
- Recall date
- December 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)