United StatesGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW (5 units per box), Product Code 60-1060, Lot 0001441871 (Shelfbox UDI‑DI: 30389701011975; Pouch UDI‑DI: 00389701011974; UDI‑PI: (17)280501(10)0001441871), distributed worldwide including the United States and Canada by Terumo Medical Corporation, is affected. It was recalled because the product was packaged with the 0.025 guidewire instead of the specified 0.021 guidewire.
What's being recalled
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Recalling firm: Terumo Medical Corporation, Elkton, MD, United States.
How to identify it
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
The hazard
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
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 distribution - US Nationwide 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