Recall Z-1680-2022 ยท HCG Device, Neurovascular Embolization
BALT USA, LLC
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
| Date | Jul 26, 2022 |
| Status | Open, Classified |
| Reason | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| Root cause | Under Investigation by firm |
| Action | On or about 07/15/2022, Balt USA LLC communicated an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" Letter informing customers that Balt became aware that finished goods were released and distributed to customers prior to the approval and release of a test report authorizing the use of existing material from an alternate supplier. On 08/08/2022 and updated/revised "URGENT MEDICAL DEVICE RECALL" letter was sent via certified mail to customers re-emphasizing the recall and providing updated instructions Customer are instructed to: -Inform within their hospital safety officers, pharmacists, |
| Quantity | 4 devices |
| Distribution | U.S.: AZ and FL O.U.S.: None |
| FDA record | Open on fda.gov |