Recall Z-2590-2018— Envoy Medical Corporation

Name: FDA recall Z-2590-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Class II · Terminated

Class II FDA medical device recall by Envoy Medical Corporation, initiated 2018-06-28, terminated 2020-11-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm: Envoy Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-06-28
Terminated: 2020-11-03
Firm location: Saint Paul, MN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.