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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72018

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

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Event summary

Timeline bucket
January 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Clinical Innovations, LLC

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

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

Z-0123-2016
Recall number
Z-0123-2016
Initiated
January 05, 2015
Classification
Class II
Status
Terminated
Recalling firm
Clinical Innovations, LLC
Quantity
827 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.

Code information

Manufacturing lot 1214-F-403 and 1214-V-424

Distribution pattern

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.