Olympus Corporation of the Americas: Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number:

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.

Details from the source

Reason for recall: 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. Distribution: US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany. Quantity: 60 units Lot/code info: Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;

UPC codes

00821925033016

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.