Z-1014-2015Class II

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

Name: Z-1014-2015 Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Creator: Clinical Innovations, LLC
Published: 2014-12-30
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2014-12-30 / Terminated / root cause: manufacturing process

FDA source

Clinical Innovations, LLC began a recall of Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO on 2014-12-30. FDA classified it as Class II and gives the reason as "Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1014-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-30
Posted: 2015-01-27
Terminated: 2015-12-28
Recalling firm: Clinical Innovations, LLC
Product: Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Product code: OQY Intrauterine Tamponade Balloon
Reason for recall: Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Clinical Innovations sent an "Urgent - Medical Device Recall" letter dated December 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They will be instructed to quarantine remaining product. A company representative will visit the hospital and retrieve the product in accordance to instructions detailed on the Representative Recall Reconciliation Instructions. The representative will reconcile the inventory on the Field Reconciliation Form and return the product to Clinical Innovations as indicated on the instructions. The address for the devices to be returned is included on the Representative Recall Reconciliation Instruct Clinical Innovations is working diligently to resolve this issue. In the meantime ,please quarantine any remaining product in your hospital. A company representative will contact you and make arrangements for the return of the product. Clinical Innovations will provide replacement product as soon as it becomes available. If you have any questions,call Clinical Innovations,at 1-(888)268-6222 or your service representative, as is the name of the Company Contact.
Quantity in commerce: 827 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
Product codes and lots: Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1014-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-27

Product code OQY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)