Recall Z-0123-2016 ยท OQY Intrauterine Tamponade Balloon
Clinical Innovations, LLC
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
| Date | Oct 15, 2015 (initiated Jan 5, 2015) |
| 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. |
| Root cause | Other |
| Action | Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices. |
| Quantity | 827 units |
| Distribution | Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150573 | ebb Complete Tamponade System Clinical Innovations, LLC, Mar 25, 2015 |