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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

FDA Recall Z-1482-2023 · Posted 2023-05-01

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeIOQ
Date Initiated2023-03-31
Product Quantity5549 units

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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