FDA recall Z-1680-2022

BALT USA, LLC · Class II · device

Product

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

Reason for recall

Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

Distribution

U.S.: AZ and FL O.U.S.: None

Key facts

Status: Ongoing
Initiation date: 2022-07-26
Report date: 2022-09-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2022