BEUDAMED
    FDA Recall Terminated

    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).

    Recall: Z-2034-2018 · Initiated May 3, 2018

    Recall

    Recall Number
    Z-2034-2018
    Event Number
    80113
    Firm
    Joerns Healthcare
    FEI Number
    3009402404
    Product Code
    IKY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 3, 2018
    Terminated
    September 28, 2023
    Address
    2100 Design Rd, Arlington, TX, 76014-4593

    Description

    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).

    Reason

    Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

    Action

    The firm initiated the recall by letter on 05/04/2018. The letter requested the consignee identify potentially affected mattresses and contact Joerns Healthcare directly to schedule on-site rework of the unit. Distributors were directed to provide the recall information to their accounts.

    Distribution

    Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland

    Quantity

    46 units