Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an

FDA device recall Z-1400-2024 · posted 2024-03-29 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

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.

Action taken

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/05/2024 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the consignee inspect the device to check for any indication of error present. If an error is detected, contact Baxter Technical Support by phone at 800-445-3720, available Monday through Thursday, between 8:00 am and 6:30 pm Eastern Time, and Friday, between 8:00 am and 6:00 pm Eastern Time, or by email at HRC_Technical_Support@baxter.com to have the pro+ mattress corrected. A Baxter representative will contact your facility to arrange for an inspection of your device and correction, if required.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

IOQ

Quantity affected

232 units

Distribution

US Nationwide distribution in the state of Colorado.

Date initiated

2024-03-05

Date posted

2024-03-29

Location

Deerfield, IL