Home / Recalls / Clinical Innovations, LLC / Z-0123-2016

Z-0123-2016 Class II Terminated

Recalled by Clinical Innovations, LLC — Murray, UT

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

Other recalls by Clinical Innovations, LLC

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  • F-1684-2022 Class II — Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of (July 19, 2022)
  • F-1685-2022 Class II — Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of (July 19, 2022)
  • Z-0541-2021 Class II — Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membra (August 13, 2020)
  • Z-2072-2020 Class II — Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The (August 6, 2019)
  • Z-2118-2020 Class II — Clearview Total Uterine Manipulator (model UM750), The device is labeled in par (May 30, 2019)
  • Z-1014-2015 Class II — Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, (December 30, 2014)