Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries
Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a labeling error regarding battery life, which fits the rubric criteria for minor labeling errors.
Plain-English summary
Advanced Bionics, LLC is recalling 53 units of the AB PowerCel 230 (velvet black) batteries, reference CI-5523-150. These batteries are used to power the Naida CI Q90, Q70, and Q30 Sound Processors for cochlear implants.
The recall was initiated because it was determined that some of the batteries were improperly labeled and may contain a different battery life than indicated on the packaging. The affected units were distributed worldwide, including nationwide in the United States and in various international locations.
Consumers who possess these specific batteries should stop using them and contact Advanced Bionics for instructions on how to proceed. The recall is limited to the specific reference number and UDI listed in the agency documentation.
The recalled product
- Product
- 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.
- Manufacturer
- Advanced Bionics, LLC
- Hazard
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 410079020
Distribution
Part of a larger recall action
This product is one of 2 recalled by Advanced Bionics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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