Recall Z-0103-2023— BALT USA, LLC

Name: FDA recall Z-0103-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-07

Class II · Ongoing

Class II FDA medical device recall by BALT USA, LLC, initiated 2022-09-07. It names 2 FDA 510(k) clearances: K200030, K172390. Product: Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.. Reason: Product pouch label does not match up with carton label.

Recalling firm: BALT USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-07
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 Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

Reason for recall

Product pouch label does not match up with carton label

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