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

Recalled February 4, 2015 · FDA recall Z-1014-2015 · Clinical Innovations

Hazard

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

Units

827 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Clinical Innovations, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →