Z-0486-2021 Class III Terminated

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
December 2, 2020
Initiation Date
September 26, 2020
Termination Date
May 4, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53 units

Product Description

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

Reason for Recall

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.

Code Information

410079020