Device product
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
Z-0572-2026
Product summary
- Event
- Event 97757
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-0572-2026
Official wording
Reason: 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.
Code information: Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
Distribution pattern: US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
Derived failure modes
-
Unknown
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.