BEUDAMED
    FDA Recall Terminated

    Respire Pink Series EF+ Oral Sleep Apnea Device.

    Recall: Z-1947-2018 · Initiated September 1, 2017

    Recall

    Recall Number
    Z-1947-2018
    Event Number
    80030
    FEI Number
    3008937561
    Product Code
    LRK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 1, 2017
    Posted
    May 29, 2018
    Terminated
    December 9, 2019
    Address
    Respire Medical 18 Bridge St, Ste 4J, Brooklyn, NY, 11201-1107

    Description

    Respire Pink Series EF+ Oral Sleep Apnea Device.

    Reason

    Potential for device breakage during use

    Action

    On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions: - Immediately examine your inventory, discontinue use and quarantine product subject to recall. - In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice. - Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge. Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.

    Distribution

    US nationwide distribution.

    Quantity

    1 unit