PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: April 10, 2024 Initiated: March 5, 2024 #Z-1400-2024

Product Description

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.

Details

Units Affected
232 units
Distribution
US Nationwide distribution in the state of Colorado.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corporation. Units affected: 232 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1400-2024.