Z-0123-2016 Class II Terminated
FDA device recall Z-0123-2016 was initiated by Clinical Innovations, LLC on January 5, 2015 and is designated Class II. 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 deli… The recall status is terminated (terminated April 21, 2016). Affected quantity: 827 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2015
- Initiation Date
- January 5, 2015
- Termination Date
- April 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 827 units
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.
Distribution Pattern
Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
Code Information
Manufacturing lot 1214-F-403 and 1214-V-424