FDA-Device2018-08-08Class II
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Envoy Medical Corporation
Hazard
Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
Sold states
US Distribution to states of: FL, OR
Affected count
4 Units
Manufactured in
4875 White Bear Pkwy, N/A, Saint Paul, MN, United States
Products
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2018Don't want to check this manually?
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