Recall Z-1014-2015 ยท OQY Intrauterine Tamponade Balloon
Clinical Innovations, LLC
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
| Date | Jan 27, 2015 (initiated Dec 30, 2014) |
| Status | Terminated |
| 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 ins |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.