Z-0486-2021 Class III Terminated
FDA device recall Z-0486-2021 was initiated by Advanced Bionics, LLC on September 26, 2020 and is designated Class III. Reason for recall: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. The recall status is terminated (terminated May 4, 2023). Affected quantity: 53 units.
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