FDAFDA · Food and drugs·Recall number Z-1699-2014
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.
Published June 11, 2014 · Recall initiated: April 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cochlear Americas Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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