FDA-Device2022-10-26Class II
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
BALT USA, LLC
Hazard
Product pouch label does not match up with carton label
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Affected count
41 impacted devices
Manufactured in
29 Parker Ste 100, N/A, Irvine, CA, United States
Products
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0103-2023Don't want to check this manually?
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