Device product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Z-0103-2023
Product summary
- Firm
- BALT USA, LLC
- Event
- Event 90870
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 41 impacted devices
- Official record key
device-enforcement:Z-0103-2023
Official wording
Reason: Product pouch label does not match up with carton label
Code information: Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Derived failure modes
-
Unknown
Product pouch label does not match up with carton label