Z-1400-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-1400-2024 was initiated by Baxter Healthcare Corporation on Mar 5, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 232 units.

Recall Details

Product Type
Devices
Report Date
Apr 10, 2024
Initiation Date
Mar 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
232 units

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.

Distribution Pattern

US Nationwide distribution in the state of Colorado.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1400-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.