United StatesAdvanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor (Model/Catalog CI-5295-150; Lot Code UDI‑DI: 08400944CI5295YJ; Serial numbers 249596 and 249603) is affected. The devices were recalled because the behind-the-ear sound processor packaging label is different than the included product.
What's being recalled
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Recalling firm: Advanced Bionics, LLC, Valencia, CA, United States.
How to identify it
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
The hazard
Behind-the-ear sound processer packaging label is different then included product.
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
Unknown
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)
Canada