The Ebb Complete Tamponade System recall
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine…
Why was The Ebb Complete Tamponade System recalled?
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
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?
Manufacturing lot 1214-F-403 and 1214-V-424
- Product
- The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine…
- Recalling firm
- Clinical Innovations, LLC
- Quantity
- 827 units
- Distribution
- Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
- Recall date
- October 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)