Recall Z-1482-2023 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
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
| Date | May 1, 2023 (initiated Mar 31, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). |
| Root cause | Process change control |
| 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. |
| Quantity | 5549 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.