Z-1400-2024Class II

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

Name: Z-1400-2024 Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the...
Creator: Baxter Healthcare Corporation
Published: 2024-03-05
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-03-05 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of 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 on 2024-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1400-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-03-29
Recalling firm: Baxter Healthcare Corporation
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.
Product code: IOQ Bed, Flotation Therapy, Powered
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.
FDA root cause: Under Investigation by firm
Action: 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 [email protected] 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.
Quantity in commerce: 232 units
Distribution: US Nationwide distribution in the state of Colorado.
Product codes and lots: UDI/DI 00887761977884, Serial Numbers: W330BP6363, W333BP6439, W334BP6477, W334BP6535, W337BP6631, W341BP6675, X047BP7353, X049BP7431, W330BP6365, W333BP6440, W334BP6478, W334BP6536, W337BP6632, W341BP6676, X047BP7354, X049BP7432, W330BP6366, W333BP6442, W334BP6480, W334BP6537, W337BP6633, W341BP6678, X047BP7355, X049BP7433, W330BP6367, W333BP6445, W334BP6481, W337BP6565, W337BP6634, W341BP6679, X047BP7356, X063BP7505, W330BP6368, W333BP6446, W334BP6485, W337BP6566, W337BP6635, W341BP6681, X047BP7357, X063BP7506, W330BP6382, W333BP6447, W334BP6486, W337BP6567, W337BP6636, W341BP6683, X047BP7358, X063BP7507, W330BP6383, W333BP6448, W334BP6487, W337BP6568, W337BP6637, W341BP6684, X047BP7359, X063BP7508, W330BP6385, W333BP6450, W334BP6489, W337BP6569, W337BP6638, W341BP6687, X047BP7360, X063BP7509, W330BP6387, W333BP6451, W334BP6492, W337BP6570, W337BP6641, X046BP7330, X047BP7361, X063BP7510, W330BP6397, W333BP6452, W334BP6493, W337BP6571, W337BP6642, X046BP7331, X047BP7362, X063BP7511, W333BP6399, W333BP6453, W334BP6496, W337BP6572, W337BP6643, X046BP7332, X047BP7363, X063BP7512, W333BP6400, W333BP6455, W334BP6500, W337BP6573, W337BP6644, X046BP7333, X047BP7364, X063BP7513, W333BP6401, W333BP6456, W334BP6501, W337BP6574, W337BP6645, X046BP7334, X047BP7365, X063BP7514, W333BP6404, W333BP6457, W334BP6502, W337BP6575, W341BP6646, X046BP7335, X047BP7366, X066BP7516, W333BP6405, W333BP6458, W334BP6504, W337BP6577, W341BP6647, X046BP7336, X047BP7367, X066BP7517, W333BP6406, W333BP6459, W334BP6505, W337BP6578, W341BP6648, X046BP7337, X047BP7368, X066BP7518, W333BP6415, W333BP6460, W334BP6511, W337BP6579, W341BP6655, X046BP7338, X047BP7369, X066BP7519, W333BP6418, W333BP6461, W334BP6513, W337BP6583, W341BP6658, X046BP7339, X047BP7370, X066BP7520, W333BP6420, W333BP6463, W334BP6514, W337BP6614, W341BP6659, X046BP7340, X047BP7371, X066BP7521, W333BP6421, W333BP6465, W334BP6525, W337BP6615, W341BP6660, X047BP7342, X047BP7372, X066BP7522, W333BP6422, W333BP6466, W334BP6526, W337BP6621, W341BP6661, X047BP7343, X047BP7373, X066BP7523, W333BP6423, W333BP6467, W334BP6527, W337BP6622, W341BP6663, X047BP7344, X047BP7374, X066BP7524, W333BP6424, W334BP6468, W334BP6528, W337BP6623, W341BP6666, X047BP7345, X047BP7375, X066BP7525, W333BP6425, W334BP6469, W334BP6529, W337BP6624, W341BP6667, X047BP7346, X047BP7376, X066BP7526, W333BP6426, W334BP6470, W334BP6530, W337BP6625, W341BP6668, X047BP7347, X047BP7378, X066BP7527, W333BP6427, W334BP6471, W334BP6531, W337BP6626, W341BP6669, X047BP7348, X047BP7379, X066BP7531, W333BP6431, W334BP6473, W334BP6532, W337BP6628, W341BP6670, X047BP7350, X047BP7381, X066BP7532, W333BP6432, W334BP6475, W334BP6533, W337BP6629, W341BP6671, X047BP7351, X049BP7429, X066BP7533, W333BP6435, W334BP6476, W334BP6534, W337BP6630, W341BP6674, X047BP7352, X049BP7430, X066BP7540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1400-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29

Product code IOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)