Baxter Healthcare Corporation Recall 90511
Description: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Baxter Healthcare Corporation Recall 90511 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1411-2022 |
| Event ID | 90511 |
| Event Description | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress. |
| Product Type | Devices |
| 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 | 200 mattresses |
| Recall 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. |
| Device Classification | 20220727 |
| Device Code Info | REF P7924A01, UDI 00887761977907; Serial numbers: W218BP4042, W218BP4054, W218BP4056, W218BP4059, W218BP4060, W218BP4061, W218BP4058, W218BP4048, W218BP4069, W218BP4053, W218BP4041, W218BP4043, W218BP4044, W218BP4045, W218BP4046, W218BP4049, W218BP4051, W218BP4052, W218BP4055, W218BP4057, W218BP4062, W218BP4063, W218BP4065, W218BP4066, W218BP4067, W336BP6549, W336BP6550, W336BP6555, W336BP6556, W336BP6557, W336BP6558, W336BP6560, W336BP6561, W336BP6562, W336BP6563, W218BP4050, W336BP6548, W337BP6609, W336BP6541, W336BP6546, W336BP6540, W336BP6542, W336BP6543, and W336BP6544. REF P7924ARENT01, UDI 00887761976863; Serial numbers: W223BP4081, W223BP4084, W242BP4397, W242BP4398, W242BP4401, W242BP4403, W242BP4405, W242BP4407, W242BP4408, W242BP4409, W242BP4410, W231BP4233, W231BP4234, W231BP4241, W231BP4243, W231BP4244, W231BP4248, W231BP4249, W231BP4252, W231BP4253, W235BP4259, W235BP4260, W235BP4265, W235BP4266, W242BP4381, W242BP4387, W242BP4391, W242BP4392, W242BP4393, W242BP4394, W242BP4395, W242BP4396, W242BP4402, W242BP4404, W243BP4412, W243BP4413, W243BP4414, W243BP4415, W243BP4416, W231BP4213, W231BP4224, W231BP4228, W231BP4229, W231BP4230, W231BP4242, W231BP4245, W231BP4246, W231BP4247, W231BP4250, W231BP4251, W242BP4390, W243BP4418, W243BP4419, W243BP4420, W243BP4421, W243BP4428, W223BP4079, W224BP4102, W224BP4108, W231BP4202, W231BP4203, W231BP4204, W231BP4207, W231BP4209, W231BP4217, W231BP4218, W231BP4220, W231BP4221, W231BP4222, W231BP4223, W231BP4227, W231BP4254, W231BP4255, W231BP4256, W223BP4091, W224BP4103, W231BP4210, W231BP4211, W231BP4214, W231BP4216, W231BP4219, W231BP4257, W235BP4261, W235BP4262, W235BP4263, W235BP4264, W239BP4361, W239BP4365, W239BP4367, W239BP4373, W239BP4375, W242BP4382, W242BP4383, W242BP4385, W242BP4386, W223BP4070, W223BP4071, W223BP4072, W223BP4073, W223BP4074, W223BP4077, W223BP4082, W223BP4083, W223BP4085, W223BP4086, W223BP4087, W223BP4088, W223BP4090, W223BP4092, W223BP4093, W224BP4096, W224BP4098, W224BP4099, W224BP4100, W224BP4101, W224BP4104, W224BP4105, W224BP4109, W224BP4110, W224BP4111, W231BP4205, W231BP4206, W231BP4208, W231BP4212, W231BP4215, W224BP4095, W224BP4097, W224BP4112, W224BP4113, W224BP4114, W224BP4106, W224BP4107, W239BP4364, W239BP4366, W239BP4369, W239BP4371, W239BP4372, W239BP4362, W239BP4368, W239BP4370, W239BP4360, W239BP4363, W239BP4374, W242BP4378, W242BP4379, W242BP4380, W242BP4384, W242BP4399, W242BP4400, W223BP4075, W223BP4080, W223BP4076, W223BP4078, W224BP4094, W224BP4115, and W224BP4116. |
| Center Classification Date | 20220720 |
| Recall Initiation Date | 20220624 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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