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Recall Observatory FDA recall evidence

Device 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.

Z-0123-2016

January 05, 2015

Class II

Product summary

Firm
Clinical Innovations, LLC
Event
Event 72018
Status
Terminated
Classification
Class II
Quantity
827 units
Official record key
device-enforcement:Z-0123-2016

Official wording

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.

Code information: Manufacturing lot 1214-F-403 and 1214-V-424

Distribution pattern: Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.