United StatesThe affected product is the IntelliCuff portable automatic cuff pressure controller (REF 951001; GTIN 07630002800839), lot numbers 00001–19732, 962 units distributed worldwide including listed U.S. states and Canada. It was recalled because the device may alarm with a “Cuff System Leakage” error, causing the motor to pump continuously and fail to maintain the cuff pressure set by the user.
What's being recalled
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Recalling firm: Hamilton Medical AG, Domat/Ems, N/A, Switzerland.
How to identify it
GTIN: 07630002800839/ Lot # range: 00001 -19732
The hazard
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
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
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.
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