HiRes Ultra 3D cochlear implants carry an incorrect expiration date
HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are being recalled due to an incorrect shelf-life expiration date. 36 units are affected.
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: FDA Class II recall for a date labeling error with no direction or consequence described in the source, which fits the minor labeling band at Moderate.
Plain-English summary
The HiResolution Bionic Ear System, HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant, model/catalog number CI-1601-04, is being recalled. The action covers 36 units.
The stated reason is an incorrect shelf-life expiration date. The FDA classified the action as Class II. The source does not state the direction of the error or describe any resulting hazard.
Distribution was nationwide in the United States, including California, Colorado, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland and Michigan. The implants are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI codes in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals
- Manufacturer
- Advanced Bionics, LLC
- Hazard
- labeling-error
- incorrect-expiration-date
- class-ii
- cochlear-implant
Distribution
Distributed nationwide across the United States.
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