Class II — Clinical Innovations, LLC
| Recalling firm | Clinical Innovations, LLC |
|---|---|
| Registered facility | CLINICAL INNOVATIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. |
| Product | Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO |
| 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. |
| Initiated | 2014-12-30 |
| Classified | 2015-01-27 |
| Terminated | 2015-12-28 |
| Recall number | Z-1014-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Clinical Innovations, LLC (Z-1014-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70137/
Alerts for Clinical Innovations, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.