Optima Coil System recall
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Why was Optima Coil System recalled?
Product pouch label does not match up with carton label
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
- Product
- Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
- Recalling firm
- BALT USA, LLC
- 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.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)