The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Reported: October 21, 2015 Initiated: January 5, 2015 #Z-0123-2016
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.
Details
- Recalling Firm
- Clinical Innovations, LLC
- Units Affected
- 827 units
- Distribution
- Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
- Location
- Murray, UT
Frequently Asked Questions
What product was recalled? ▼
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.. Recalled by Clinical Innovations, LLC. Units affected: 827 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2015. Severity: Moderate. Recall number: Z-0123-2016.
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