BALT USA, LLC: Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK

Hazard

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

Details from the source

Reason for recall: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, Quantity: 2889 devices Lot/code info: Product Description/Product Catalog Number/UDI-DI/Lot Numbers: OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800506 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800507 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800579 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800885 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800480 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800581 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800722 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800857 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800858 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800854 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800855 OptiBLOCK Coil 2.5mm x 8cm OptiBLOCK Complex OPTI0258BLK 00810068568929 F230800768 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800514 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800525 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800577 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800770 OptiBLOCK Coil 2mm x 12cm OptiBLOC

UPC codes

00810068568875, 00810068568882, 00810068568851, 00810068568929, 00810068568912, 00810068568905, 00810068568943, 00810068568950, 00818053026614, 00840303701002, 00818053026621, 00818053022135, 00840303701019, 00818053026638, 00818053025761, 00840303701026, 00840303700142, 00818053027086, 00818053026461, 00818053021978, 00818053026478, 00818053026515, 00818053022029, 00818053025709, 00840303700951, 00818053025716, 00840303700968, 00818053021381, 00818053026591, 00818053025723, 00818053022104, 00818053026607, 00840303700548, 00840303700203, 00818053025853, 00818053026737, 00840303701118, 00818053021510, 00840303701040, 00818053026669

Source

Official record: FDA (Device enforcement) ↗

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