Device product

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

Z-1014-2015

December 30, 2014

Class II

Product summary

Firm: Clinical Innovations, LLC
Event: Event 70137
Status: Terminated
Classification: Class II
Quantity: 827 units
Official record key: device-enforcement:Z-1014-2015

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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