Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70137

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

Open FDA event record

Event summary

Timeline bucket
December 30, 2014
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

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

Z-1014-2015
Recall number
Z-1014-2015
Initiated
December 30, 2014
Classification
Class II
Status
Terminated
Recalling firm
Clinical Innovations, LLC
Quantity
827 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.

Code information

Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

Distribution pattern

Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.

Field note

Send feedback

We'll only use this to respond to your feedback.