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Recall Observatory FDA recall evidence

Device product

Cellfina Prep Pack, Part No. CP1

Z-0749-2017

November 14, 2016

Class II

Product summary

Firm
Ulthera Inc
Event
Event 75682
Status
Terminated
Classification
Class II
Quantity
6562 units
Official record key
device-enforcement:Z-0749-2017

Official wording

Reason: 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.

Code information: all

Distribution pattern: Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.