Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Reported: October 26, 2022 Initiated: September 7, 2022 #Z-0103-2023
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
Details
- Recalling Firm
- BALT USA, LLC
- Units Affected
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.. Recalled by BALT USA, LLC. Units affected: 41 impacted devices.
Why was this product recalled? ▼
Product pouch label does not match up with carton label
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0103-2023.
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