United StatesThe affected product is the Olympus Nephro‑EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit, model/catalog BPCN0815K (UDI 00821925033016), lot 25037006 — 60 units distributed in AK, CA, IA, KY, WA, WI, Canada and Germany. Kits were recalled because they contained an incorrectly sized 4 mm x 4 cm urinary tract balloon catheter (BURS0404) instead of the correct 8 mm x 15 cm nephrostomy tract balloon catheter (BPCN0815).
What's being recalled
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
The hazard
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
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 Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
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)