Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0123-2016 — The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

U.S. FDA — Device Enforcement · United States · 2015-01-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0123-2016
Date of alert: 2015-01-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Clinical Innovations, LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0123-2016 — The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

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