Ebb Complete Tamponade System recall
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Why was Ebb Complete Tamponade System recalled?
Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
- Product
- Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
- Recalling firm
- Clinical Innovations, LLC
- 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.
- Recall date
- February 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)