FDA Device recall Z-1014-2015
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO by Clinical Innovations, citing potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1014-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-30 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clinical Innovations |
| Distribution | US |
Product
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Reason
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Identifiers
| code_info | Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1014-2015%22
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