FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: 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.
- Recall number
- Z-1400-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-03-05
- Posted
- 2024-03-29
- Terminated
- not on file
- Reason
- 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.
- 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 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.
- Quantity
- 232 units
- Distribution
- US Nationwide distribution in the state of Colorado.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IOQ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28