United StatesFinesse BTK Multicath Injectable Angioplasty Balloon Catheter (Model/Catalog FS252251502, UDI-DI 00810017490967; lots 240502, 240095, 231296, 231296A, 240095A) — a 5 French sheath, 0.014" guidewire-compatible over-the-wire catheter with a 2.5 mm × 225 mm balloon and 150 cm working length — distributed in New Jersey and Florida. It was recalled because the balloon may not meet burst specifications.
What's being recalled
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Recalling firm: Summa Therapeutics, LLC, Allston, MA, United States.
How to identify it
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
The hazard
Potential for the balloon in the device to not meet burst 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
US Nationwide distribution in the states of New Jersey, Florida.
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)