Reported Jun 11, 2014 · Terminated
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less…
Cochlear Americas Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cochlear Americas Inc. · 13059 E Peakview Ave · Centennial, CO · 80111-6511
Is this the product you have?
- 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.
- Lot codes and dates
Outer Package Lot COH523440COH485876and COH484221 with/Device Lot No. 131008
- Amount recalled
- 288
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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