Recall Z-1680-2022— BALT USA, LLC

Name: FDA recall Z-1680-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-26

Class II · Ongoing

Class II FDA medical device recall by BALT USA, LLC, initiated 2022-07-26. It names 2 FDA 510(k) clearances: K200030, K172390. Product: Optima Coil System Model OPTI0520CSF10. For endovascular embolization.. Reason: 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..

Recalling firm: BALT USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-07-26
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K200030 — Optima Coil SystemBalt USA, LLC·cleared 2020-02-01
K172390 — Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)·cleared 2018-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.