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Advanced Bionics, LLC recalls AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI
Recalled December 2, 2020 · FDA recall Z-0487-2021 · Advanced Bionics
Hazard
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. · FDA Class III
Units
28 units
Sold at
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.
Description
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Product
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 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(s)
Advanced Bionics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →