United StatesOn-X Mitral Heart Valve with Conform‑X Sewing Ring, model ONXMC-25/33 (UDI‑DI 00851788001303), serial numbers A2013401–A2013411 (except A2013406), expiration 2031‑12‑17, distributed to South Korea, is affected. The valves were released and distributed before all required testing was complete, so it cannot be confirmed they meet all release specifications.
What's being recalled
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Recalling firm: On-X Life Technologies, Inc., Austin, TX, United States.
How to identify it
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
The hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the country of South Korea.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)