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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75682

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 14, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ulthera Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Cellfina Prep Pack, Part No. CP1

Z-0749-2017
Recall number
Z-0749-2017
Initiated
November 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ulthera Inc
Quantity
6562 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

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.

Code information

all

Distribution pattern

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