Clinical Innovations, LLC recalls Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- Recall date
- December 30, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1014-2015
- FDA classification
- Class II
- Brand / firm
- Clinical Innovations, LLC
- Sold / 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.
Why it was recalled
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
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