FDAFDA · Food and drugs·Recall number Z-2590-2018
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.
Published August 8, 2018 · Recall initiated: June 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Envoy Medical Corporation
- Distributor
- US Distribution to states of: FL, OR
- Lot
- Lot Numbers: EMC0006145, EMC0006155, & EMC0006217
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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