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BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Recalled October 26, 2022 · FDA recall Z-0103-2023 · BALT USA
Hazard
Product pouch label does not match up with carton label · FDA Class II
Units
41 impacted devices
Sold at
Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Description
Product pouch label does not match up with carton label
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Manufacturer(s)
BALT USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →