Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Reported: February 4, 2015 Initiated: December 30, 2014 #Z-1014-2015
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.
Details
- Recalling Firm
- Clinical Innovations, LLC
- Units Affected
- 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.
- Location
- Murray, UT
Frequently Asked Questions
What product was recalled? ▼
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO. Recalled by Clinical Innovations, LLC. Units affected: 827 units.
Why was this product recalled? ▼
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1014-2015.
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