CLASS II Device recall · Reported 4 Feb 2015 · FDA Enforcement Report
Ebb Complete Tamponade System, Bd-ots Obstetric Catheter recalled
Clinical Innovations is recalling Ebb Complete Tamponade System, Bd-ots Obstetric Catheter, distributed nationwide in the US. The recall was initiated on 30 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1014-2015
- FDA event ID
- 70137
- Recalling firm
- Clinical Innovations, Murray, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2014
- FDA classified
- 27 Jan 2015
- Reported
- 4 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 30 Dec 2014 | Recall initiated by company | |
| 27 Jan 2015 | Classified by FDA | +28 days |
| 4 Feb 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
Questions about this recall
Why was it recalled?
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Which lots are affected?
Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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