BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2590-2018 · Initiated June 28, 2018

    Recall

    Recall Number
    Z-2590-2018
    Event Number
    80489
    Firm
    Envoy Medical Corporation
    FEI Number
    3004007782
    Product Code
    OAF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 28, 2018
    Terminated
    November 3, 2020
    Address
    4875 White Bear Pkwy, Saint Paul, MN, 55110-3325

    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

    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.

    Action

    The firm notified its customers via email on 06/18/2018 and 06/19/2018. The 06/18/2018 email to a customer stated Envoy Medical would like to have the devices the customer has on site returned, as apparently, it was confirmed that each device is packaged with a wipe that shows expired just on the wipe only. Envoy will replace the recalled devices by overnight shipping replacements. The 06/19/2018 email to a customer stated it was discovered that the sound processors (primary and backup) were previously sent to the site have a wipe in them that show an expired date on the packaging. The email also stated this is something that doesn't affect the actual sound processor itself as those are good, but just to be on the safe side, make sure the 2 sound processors currently at the site (serial #s 213658 and 213729) are returned to Envoy Medical ASAP so we can have them repackaged with wipes within their expiration dates added to the sound processor packaging. Envoy will send out 2 new Sound Processors (primary and backup). Both emails contained Envoy Medical contact information for the consignees in case any questions or concerns arose.

    Distribution

    US Distribution to states of: FL, OR

    Quantity

    4 Units