Recall Z-0123-2016— Clinical Innovations, LLC
Class II · Terminated
Class II FDA medical device recall by Clinical Innovations, LLC, initiated 2015-01-05, terminated 2016-04-21. It names one FDA 510(k) clearance: K150573. 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.. 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..
- Recalling firm
- Clinical Innovations, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-05
- Terminated
- 2016-04-21
- Firm location
- Murray, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.