Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Recall #Z-1014-2015 — Class II — December 30, 2014
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.
Recalling Firm
Clinical Innovations, LLC — Murray, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
827 units
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated