Z-0103-2023 Class II Ongoing
FDA device recall Z-0103-2023 was initiated by BALT USA, LLC on September 7, 2022 and is designated Class II. Reason for recall: Product pouch label does not match up with carton label The recall status is ongoing. Affected quantity: 41 impacted devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 impacted devices
Product Description
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Reason for Recall
Product pouch label does not match up with carton label
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.
Code Information
Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089