Advanced Bionics sound processor packaging label does not match contents
Advanced Bionics is recalling two Sky CI M90 Sound Processors because the behind-the-ear sound processor packaging label differs from the product included in the pack.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the packaging label does not match the enclosed product, and the source describes no defect or malfunction in the device.
Plain-English summary
Advanced Bionics, LLC is recalling the Sky CI M90 Sound Processor, part of the HiResolution Bionic Ear System, model CI-5295-150. Two units are affected. The FDA has classified this recall as Class II.
The behind-the-ear sound processor packaging label is different to the product included in the pack. The source record does not describe a defect or malfunction in the device itself.
Affected product carries UDI-DI 08400944CI5295YJ and serial numbers 249596 and 249603.
Facilities can identify affected units by the model number, UDI and serial numbers above, and may contact Advanced Bionics, LLC for further information.
The recalled product
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Manufacturer
- Advanced Bionics, LLC
- Category
- Medical Device — Hearing implant
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 249603
Distribution
Distribution scope not specified by the agency.
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