Ebb Complete Tamponade System — Class II medical device recall Z-1014-2015
Terminated recall by Clinical Innovations, LLC, reported 2015-02-04, distributed nationwide. Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
| Recall number | Z-1014-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Innovations, LLC, Murray, UT, United States |
| Recall initiated | 2014-12-30 |
| Classified | 2015-01-27 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, DE, EE, ES, FI, FR, GB, IE, NL, SE |
| Quantity | 827 units |
| Reason classes | packaging |
| Lot numbers | 0314-F-566, 0814-F-100, 0814-F-108, 0814-V-068 |
| Model numbers | CTS-1000 |
Product
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Reason for recall
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1014-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.