FDADecember 30, 2014device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

clinical innovationsclinical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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