Reported Dec 2, 2020 · Terminated
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da…
Advanced Bionics, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics, LLC · 28515 Westinghouse Pl · Valencia, CA · 91355-1398
Is this the product you have?
- AB PowerCel 230 (velvet black)
- REFCI-5523-150
- UDI(01) 07630016832956
- used to power the following devicesNa¿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
- Lot codes and dates
- 410079020
- Amount recalled
- 53 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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