United StatesThe ClariTEE Miniaturized TEE probe, model CLT-010 (UDI‑DI 00861589000108, lot 20261209) for use with ImaCor Mobile Ultrasound model ZHH is being recalled; 45 units were distributed in the United States, including South Carolina, New Jersey, Pennsylvania, Florida, and Georgia. The recall is due to a production assembly error that can reverse articulation, so moving the lever forward causes the probe tip to anteflex rather than retroflex, and vice versa.
What's being recalled
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Recalling firm: ImaCor Inc., Jericho, NY, United States.
How to identify it
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
The hazard
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
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
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
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)