Reported Oct 21, 2015 · Terminated
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or…
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?
- The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
- Lot codes and dates
- Manufacturing lot 1214-F-403 and 1214-V-424
- Amount recalled
- 827 units
Where it was sold
Why it was recalled
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
This product could cause temporary or reversible health problems — stop using it.
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