FDA Enforcement Class II Ongoing

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

Recall: Z-1412-2022 · Reported July 27, 2022

Enforcement

Recall Number: Z-1412-2022
Event ID: 90511
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Baxter Healthcare Corporation
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: July 27, 2022
Initiation Date: June 24, 2022
Classification Date: July 20, 2022
Address: 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

Description

Reason

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.

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.

Distribution

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.

Quantity

404 mattresses