FDAJune 28, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
envoy medicalenvoy
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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