Reported Feb 4, 2015 · Terminated

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

Clinical Innovations, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Clinical Innovations, LLC · 747 W 4170 S · Murray, UT · 84123-1364

Is this the product you have?

  • Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Lot codes and dates
  • Lots
    • 0314-F-566
    • 0814-F-100
    • 0814-F-108
    • 0814-V-068
Amount recalled
827 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 28, 2015 · Data as of Sep 19, 4:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.