Z-0123-2016Class II

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary...

Name: Z-0123-2016 The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary...
Creator: Clinical Innovations, LLC
Published: 2015-01-05
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2015-01-05 / Terminated

FDA source

Clinical Innovations, LLC began a recall of The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding on 2015-01-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0123-2016
Classification: Class II
Status: Terminated
Initiated: 2015-01-05
Posted: 2015-10-15
Terminated: 2016-04-21
Recalling firm: Clinical Innovations, LLC
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.
Product code: OQY Intrauterine Tamponade Balloon
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.
FDA root cause: Other
Action: Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
Quantity in commerce: 827 units
Distribution: Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
Product codes and lots: Manufacturing lot 1214-F-403 and 1214-V-424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-15

Product code OQY

K150573Class IIebb Complete Tamponade SystemClinical Innovations, LLC / cleared 2015-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)