Advanced Bionics Sky CI M90 processor recalled for label mismatch
Advanced Bionics is recalling certain Sky CI M90 Sound Processors because the label on the package does not match the product inside. Two units with specific serial numbers (249596 and 249603) are affected. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check if your Sky CI M90 Sound Processor has serial number 249596 or 249603
- Compare the product packaging label to the actual device inside
- Contact Advanced Bionics or your healthcare provider if you have one of the affected units
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 2 units
- Illnesses reported
- None reported
- Manufactured in
- 28515 Westinghouse Pl, N/A, Valencia, CA, United States
- Classification
- Class II
- Recall number
- Z-1493-2026
In the FDA's words
- Description
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 Behind-the-ear sound processer packaging label is different then included product. Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603 Distribution: Unknown Affected quantity: 2 units
- Hazard
- Behind-the-ear sound processer packaging label is different then included product.