FDA-Device2022-10-26Class II
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
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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