Z-1813-2025 Class II Ongoing

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
May 28, 2025
Initiation Date
March 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 chargers

Product Description

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Reason for Recall

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Distribution Pattern

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Code Information

M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967