Reported Dec 21, 2016 · Terminated
Cellfina Prep Pack, Part No. CP1
Ulthera Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ulthera Inc · 1840 S Stapley Dr Ste 200 · Mesa, AZ · 85204-6681
Is this the product you have?
- Cellfina Prep Pack, Part No. CP1
- Lot codes and dates
- all
- Amount recalled
- 6562 units
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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