FDAFDA · Food and drugs·Recall number Z-0487-2021
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.
Published December 2, 2020 · Recall initiated: September 26, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Bionics, LLC
- Distributor
- 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.
- Lot
- 410078519
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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