Reported Aug 8, 2018 · Terminated
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018).…
Envoy Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Envoy Medical Corporation · 4875 White Bear Pkwy · Saint Paul, MN · 55110-3325
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
EMC0006145EMC0006155& EMC0006217
- Lot Numbers
- Amount recalled
- 4 Units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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