FDA recall Z-0103-2023

BALT USA, LLC · Class II · device

Product

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

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

Key facts

Status
Ongoing
Initiation date
2022-09-07
Report date
2022-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0103-2023