Z-1724-2025 Class II Ongoing

Recalled by Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
April 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

Reason for Recall

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Distribution Pattern

US Nationwide distribution in the states of TX, MT, AL & OK.

Code Information

Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.