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Envoy Medical Corporation recalls Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018).
Recalled August 8, 2018 · FDA recall Z-2590-2018 · Envoy Medical
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. · FDA Class II
Units
4 Units
Sold at
US Distribution to states of: FL, OR
Description
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.
Product
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.
Manufacturer(s)
Envoy Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →