The Recall Desk

FDA (Devices) recall action 86536

Advanced Bionics, LLC recalled 2 products on 2020-12-02

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-02
Critical
0
Units
81

Why these products were recalled

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2020-12-02

    Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries

    Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.

    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.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2020-12-02

    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.

    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.
    Category
    Distribution
    13 states