Z-2590-2018 Class II Terminated
FDA device recall Z-2590-2018 was initiated by Envoy Medical Corporation on June 28, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated November 3, 2020). Affected quantity: 4 Units.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- June 28, 2018
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 Units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to states of: FL, OR
Code Information
Lot Numbers: EMC0006145, EMC0006155, & EMC0006217