HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Company
- Advanced Bionics, Llc
- Recall Initiated
- March 5, 2025
- Posted
- May 22, 2025
- Recall Number
- Z-1813-2025
- Quantity
- 6 chargers
- Firm Location
- Valencia, CA
Reason for Recall
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Distribution
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Lot / Code Info
M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
Root Cause
Under Investigation by firm
Action Taken
On 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 410488967 and/or 410488966 Customers are instructed to: 2. Return the affected chargers to Advance Bionics. Advance Bionics will provide the correct charger to customer and will confirm receipt and return of the affected chargers. For questions contact customer service at 877-829-0026 or email Customerservice@advancebionics.com