Recall Z-0103-2023 ยท HCG Device, Neurovascular Embolization
BALT USA, LLC
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
| Date | Oct 20, 2022 (initiated Sep 7, 2022) |
| Status | Open, Classified |
| Reason | Product pouch label does not match up with carton label |
| Root cause | Error in labeling |
| Action | On 09/07/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via priority mail to customer informing them that Balt USA was informed that one device had information on the pouch label that differed from the information on the carton label. This hazard presents a high risk to patient safety with the possibility that the user could inadvertently select the wrong size coil for a procedure. Distributor/Subsidiaries are instructed to: -Inform customers about this notice. -Return to Balt USA products from Lot #F2206001068 and Lot #F220601089 Direct Customers are instructed to: -Inform wit |
| Quantity | 41 impacted devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan. |
| FDA record | Open on fda.gov |