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Terminated

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

FDA Recall Z-0123-2016 · Posted 2015-10-15

Recalling FirmClinical Innovations, LLC
Recall StatusTerminated
Product CodeOQY
Date Initiated2015-01-05
Date Terminated2016-04-21
Product Quantity827 units

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.

Firm Action

Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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