FDANovember 14, 2016device
Cellfina Prep Pack, Part No. CP1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
ulthera
Recall history
No related federal recalls on record for this brand yet.
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