United StatesThe affected product is the BiDop 3 Pocket Doppler (model ES-100V3) packaged with a 2 MHz BT2M20S8C fetal probe (Lot Codes: BIDOP 3 #00894912002043 and BT2M20S8C #00894912002326), distributed nationwide in the U.S. (34 units) to listed states. It was recalled because its product labeling includes a fetal indication for use that is not cleared under its 510(k).
What's being recalled
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Recalling firm: Koven Technology, Inc., Saint Louis, MO, United States.
How to identify it
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
The hazard
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
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 LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
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)