FDA Medical Device Recalls (openFDA)
Clinical Innovations, LLC: Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- Recall number
- Z-1014-2015
- Recalling firm
- Clinical Innovations, LLC
- Product
- Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- Status
- Terminated
- Initiated
- 2014-12-30
- Posted
- 2015-01-27
- Terminated
- 2015-12-28
- Reason
- Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
- 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
- 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.
- Lot, serial or model codes
- Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OQY
- Firm FEI
- 1000220650
- Firm city
- Murray
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28