Z-1813-2025 Class II Ongoing
FDA device recall Z-1813-2025 was initiated by Advanced Bionics, LLC on March 5, 2025 and is designated Class II. Reason for recall: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. The recall status is ongoing. Affected quantity: 6 chargers.
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