Home / Recalls / Clinical Innovations, LLC / Z-1014-2015

Z-1014-2015 Class II Terminated

Recalled by Clinical Innovations, LLC — Murray, UT

Recall Details

Product Type
Devices
Report Date
February 4, 2015
Initiation Date
December 30, 2014
Termination Date
December 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
827 units

Product Description

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

Reason for Recall

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

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.

Code Information

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

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  • Z-2118-2020 Class II — Clearview Total Uterine Manipulator (model UM750), The device is labeled in par (May 30, 2019)
  • Z-0123-2016 Class II — The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for (January 5, 2015)