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Recall Observatory FDA recall evidence

Device 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.

Z-2590-2018

June 28, 2018

Class II

Product summary

Firm
Envoy Medical Corporation
Event
Event 80489
Status
Terminated
Classification
Class II
Quantity
4 Units
Official record key
device-enforcement:Z-2590-2018

Official wording

Reason: 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.

Code information: Lot Numbers: EMC0006145, EMC0006155, & EMC0006217

Distribution pattern: US Distribution to states of: FL, OR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.