FDA recall Z-1482-2023

Baxter Healthcare Corporation · Class II · device

Product

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 for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-03-31
Report date
2023-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1482-2023