Class II

Medical Device Recall: 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.

Baxter Healthcare Corporation · March 5, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

232 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1400-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Baxter Healthcare Corporation Medical Device Recall: 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. | SafeCheck