FDA-Device2015-02-04Class II
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Clinical Innovations, LLC
Hazard
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
Affected count
827 units
Manufactured in
747 W 4170 S, N/A, Murray, UT, United States
Products
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1014-2015Don't want to check this manually?
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