BEUDAMED
    FDA Recall Open, Classified

    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01

    Recall: Z-1482-2023 · Initiated March 31, 2023

    Recall

    Recall Number
    Z-1482-2023
    Event Number
    91967
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    IOQ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 31, 2023
    Posted
    May 1, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01

    Reason

    There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

    Action

    Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/31/2023 by US mail. The notice explained the issue and the risk and requested the following actions be taken: Identify the affected product and examine the cover for damage, if damaged, discontinue use. (undamaged device may be safely used) The mattresses will be replaced. If the product was further distributed please forward a copy of the notice. For questions, contact Baxter Technical support team at 1-800-445-3720 option 2, Monday to Friday, between the hours of 8am to 6pm EST.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Qatar.

    Quantity

    5549 units