—#206541

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.

FDA product code: IOQ — Bed, Flotation Therapy, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution in the state of Colorado.

Timeline

Recall initiated: 2024-03-05
Posted by FDA: 2024-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206541. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.