—#194758

Product

Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.

FDA product code: IOQ — Bed, Flotation Therapy, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: UDI 00887761977884; Serial numbers: W225BP4122, W225BP4148, W225BP4154, W225BP4155, W225BP4157, W225BP4158, W225BP4161, W225BP4162, W225BP4167, W225BP4170, W225BP4117, W225BP4124, W225BP4126, W225BP4127, W225BP4129, W225BP4130, W225BP4134, W225BP4138, W225BP4139, W225BP4140, W225BP4141, W225BP4142, W225BP4146, W225BP4152, W225BP4153, W225BP4156, W225BP4159, W225BP4164, W225BP4165, W225BP4166, W225BP4168, W225BP4169, W225BP4171, W225BP4172, W225BP4147, W225BP4118, W225BP4160, W225BP4119, W225BP4120, W225BP4123, W225BP4145, W334BP6515, W337BP6576, W337BP6580, W334BP6516, W337BP6584, W333BP6408, W333BP6410, W334BP6519, W337BP6581, W337BP6582, W337BP6585, W334BP6469, W334BP6485, W334BP6514, W337BP6567, W337BP6568, W337BP6569, W337BP6570, W337BP6571, W337BP6574, W337BP6575, W337BP6577, W337BP6579, W337BP6614, W337BP6615, W337BP6621, W337BP6630, W337BP6636, W337BP6641, W337BP6642, W337BP6643, W337BP6644, W337BP6645, W341BP6675, W341BP6676, W341BP6684, W341BP6646, W341BP6681, W341BP6683, W330BP6387, W334BP6477, W334BP6478, W334BP6481, W334BP6534, W334BP6535, W337BP6565, W337BP6566, W337BP6572, W337BP6573, W337BP6578, W337BP6622, W337BP6623, W337BP6624, W337BP6625, W337BP6626, W337BP6628, W337BP6629, W337BP6631, W337BP6632, W337BP6633, W337BP6634, W337BP6635, W337BP6637, W337BP6638, W341BP6648, W341BP6655, W341BP6658, W341BP6659, W341BP6660, W341BP6661, W341BP6678, W341BP6679, W341BP6687, W334BP6509, W334BP6512, W334BP6523, W334BP6524, W330BP6367, W330BP6382, W330BP6383, W330BP6385, W333BP6399, W333BP6400, W333BP6415, W333BP6440, W333BP6442, W333BP6445, W333BP6450, W333BP6451, W333BP6453, W333BP6455, W333BP6458, W333BP6460, W334BP6471, W334BP6473, W334BP6475, W334BP6476, W334BP6486, W334BP6493, W334BP6496, W334BP6500, W334BP6501, W334BP6502, W334BP6504, W334BP6513, W334BP6525, W334BP6526, W334BP6527, W334BP6528, W334BP6529, W334BP6530, W334BP6531, W334BP6532, W334BP6533, W334BP6536, W334BP6537, W330BP6366, W333BP6406, W333BP6456, W333BP6459, W333BP6461, W333BP6463, W333BP6465, W333BP6466, W333BP6467, W334BP6470, W334BP6511, W337BP6583, W330BP6363, W330BP6365, W330BP6368, W330BP6397, W333BP6401, W333BP6404, W333BP6405, W333BP6418, W333BP6420, W333BP6421, W333BP6422, W333BP6423, W333BP6424, W333BP6425, W333BP6426, W333BP6427, W333BP6431, W333BP6432, W333BP6435, W333BP6439, W333BP6446, W333BP6447, W333BP6448, W333BP6452, W333BP6457, W334BP6468, W334BP6480, W334BP6487, W334BP6489, W334BP6492, W334BP6505, X047BP7341, X047BP7349, X049BP7434, X049BP7436, X049BP7438, X049BP7439, X049BP7442, X049BP7445, X049BP7446, X049BP7450, X052BP7453, X052BP7454, X052BP7458, X052BP7459, X046BP7330, X046BP7331, X046BP7332, X046BP7333, X046BP7334, X046BP7335, X046BP7336, X046BP7337, X046BP7338, X046BP7339, X046BP7340, X047BP7342, X047BP7343, X047BP7344, X047BP7345, X047BP7346, X047BP7347, X047BP7350, X047BP7351, X047BP7352, X047BP7353, X047BP7354, X047BP7355, X047BP7356, X047BP7357, X047BP7358, X047BP7359, X047BP7360, X047BP7361, X047BP7362, X047BP7363, X047BP7364, X047BP7365, X047BP7366, X047BP7367, X047BP7368, X047BP7369, X047BP7370, X047BP7371, X047BP7372, X047BP7373, X047BP7374, X047BP7375, X047BP7376, X047BP7377, X047BP7378, X047BP7379, X047BP7381, X049BP7427, X049BP7428, X049BP7429, X049BP7430, X049BP7431, X049BP7432, X049BP7433, X049BP7440, X049BP7441, X049BP7447, X052BP7451, X052BP7452, X061BP7486, X061BP7487, X062BP7499, X062BP7500, X062BP7502, X062BP7503, X062BP7504, W341BP6647, W341BP6663, W341BP6666, W341BP6667, W341BP6668, W341BP6669, W341BP6670, W341BP6671, W341BP6674, X047BP7348, X063BP7505, X063BP7506, X063BP7507, X063BP7508, X063BP7509, X063BP7510, X063BP7511, X063BP7512, X063BP7513, X063BP7514, X066BP7516, X066BP7517, X066BP7518, X066BP7519, X066BP7520, X066BP7521, X066BP7522, X066BP7523, X066BP7524, X066BP7525, X066BP7526, X066BP7527, X066BP7531, X066BP7532, X066BP7533, X066BP7540, X066BP7528, X066BP7529, X066BP7541, X066BP7542, X074BP7622, X066BP7551, X067BP7562, X067BP7563, X067BP7566, X067BP7569, X067BP7570, X067BP7571, X067BP7572, X067BP7573, X067BP7574, X067BP7575, X067BP7577, X067BP7578, X067BP7579, X067BP7580, X067BP7582, X070BP7608, X070BP7610, X070BP7615, X070BP7616, X070BP7617, X074BP7619, X074BP7620, X074BP7621, X074BP7623, X074BP7624, X074BP7625, X066BP7539, X049BP7443, X049BP7448, X049BP7449, X052BP7455, X052BP7456, X052BP7457, X052BP7460, X052BP7461, X052BP7462, X052BP7463, X052BP7464, X066BP7534, X066BP7535, X066BP7536, X066BP7537, X066BP7538, X066BP7543, X066BP7544, X066BP7545, X066BP7547, X066BP7549, X066BP7550 X066BP7552, X066BP7553, X066BP7555, X066BP7556, X066BP7557, X066BP7558, X066BP7559, X067BP7564, X067BP7565, X067BP7567, X067BP7585, X067BP7586, X067BP7587, X067BP7590, X067BP7591, X067BP7592, X067BP7594, X067BP7595, X067BP7597, X070BP7598, X070BP7599, X070BP7600, X070BP7601, X070BP7602, X070BP7603, X070BP7604, X070BP7605, X070BP7607, X070BP7611, X070BP7612, X070BP7613, and X070BP7614.

Why it was recalled

The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. Distributors were instructed to share the notification with their end users. A response form was attached to be completed and returned within 2 weeks to confirm they have reviewed and understand the attached letter and that distributors have shared the notification with their end users and will complete the field action

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.

Timeline

Recall initiated: 2022-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194758. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.