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 | 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. |
| Product | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding. |
| Quantity | 827 units |
| Distribution | Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France. |
| Initiated | 2015-01-05 |
| Classified | 2015-10-15 |
| Terminated | 2016-04-21 |
| Recall number | Z-0123-2016 |
| 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-0123-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72018/
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