FDA-Device2014-06-11Class II
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Cochlear Americas Inc.
Hazard
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
Sold states
Nationwide Distribution.
Affected count
288
Manufactured in
13059 E Peakview Ave, Centennial, CO, United States
Products
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2014Don't want to check this manually?
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