BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
FDA Recall #Z-1754-2025 — Class II — April 21, 2025
Product Description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reason for Recall
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Recalling Firm
Numed Inc — Hopkinton, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 units
Distribution
US distribution to Pennsylvania.
Code Information
Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated