medical Class II Updated 2018-08-08

Envoy Medical Corporation recalls Final Pack, Esteem II, Sound Processor Model 2001, containin

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Affected States: FL, OR
Lot/Code Info: Lot Numbers: EMC0006145, EMC0006155, & EMC0006217
View official government recall

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