FDA recall Z-1400-2024

Baxter Healthcare Corporation · Class II · device

Product

Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.

Reason for recall

Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.

Distribution

US Nationwide distribution in the state of Colorado.

Key facts

Status
Ongoing
Initiation date
2024-03-05
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1400-2024