BALT USA, LLC: Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

Hazard

Product pouch label does not match up with carton label

Details from the source

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. Quantity: 41 impacted devices Lot/code info: Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

UPC codes

00818053025815, 00818053025891

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.