Recall Z-1014-2015— Clinical Innovations, LLC
Class II · Terminated
Class II FDA medical device recall by Clinical Innovations, LLC, initiated 2014-12-30, terminated 2015-12-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO. Reason: Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014..
- Recalling firm
- Clinical Innovations, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-30
- Terminated
- 2015-12-28
- Firm location
- Murray, UT, United States
Product description
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Reason for recall
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Data sourced from openFDA. This site is unofficial and independent of the FDA.