AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI
FDA device recall Z-0486-2021 · posted 2020-11-25 · Terminated
Recall details
- Recalling firm
- Advanced Bionics, LLC
- Reason for recall
- Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
- Action taken
- On 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MCM
- Quantity affected
- 53 units
- Distribution
- 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,
- Date initiated
- 2020-09-26
- Date posted
- 2020-11-25
- Date terminated
- 2023-05-04
- Location
- Valencia, CA
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