Clinical Innovations, LLC: Medical Device Recall in 2015 - (Recall #: Z-1014-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 30, 2014

Date Posted: February 4, 2015

Recall Number: Z-1014-2015

Event ID: 70137

Reason for Recall:

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

Status: Terminated

Product Quantity: 827 units

Code Information:

Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated