Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2018-06-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2590-2018
Date of alert
2018-06-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Envoy Medical Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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