The Recall Desk
HighFDA (Devices)·Z-1014-2015·Announced 2015-02-04

Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (balloon leak in an obstetric device) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System, BD-OTS Obstetric Catheter (REF CTS-1000). The recall affects lots 0314-F-566, 0814-F-100, 0814-F-108, and 0814-V-068, which were manufactured since August 2014. The product is a prescription-only, sterile medical device distributed nationwide in the United States and in several international markets, including Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, the Netherlands, the Middle East, Scotland, Germany, and Wales.

The recall was initiated due to a potential for a balloon leak in the affected lots. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The agency classifies this recall as Class II.

Healthcare providers and patients should stop using the affected lots of the Ebb Complete Tamponade System. Clinical Innovations, LLC is the recalling firm responsible for managing the recall. Consumers and healthcare facilities should contact the manufacturer for further instructions on how to return or dispose of the affected units.

The recalled product

Product
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Manufacturer
Clinical Innovations, LLC
Category
Medical Device — Obstetric Catheter
Hazard
Affected units
827

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Clinical Innovations, LLC

See all →