The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or red
FDA device recall Z-0123-2016 · posted 2015-10-15 · Terminated
Recall details
- Recalling firm
- Clinical Innovations, LLC
- Reason for recall
- 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.
- Action taken
- Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- OQY
- Quantity affected
- 827 units
- Distribution
- Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
- Date initiated
- 2015-01-05
- Date posted
- 2015-10-15
- Date terminated
- 2016-04-21
- Location
- Murray, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ebb Complete Tamponade System (K150573) | Clinical Innovations, LLC | 2015-03-25 |