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FDA (Device enforcement)Recalled 2022-06-24class ii

Baxter Healthcare Corporation: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.

Is my product affected?

Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.

  • UPC 00887761977907
  • UPC 00887761976863

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 200 Hill-Rom PRO+ 36" MRS Surface mattresses with X-Ray features distributed worldwide, including across numerous U.S. states and Canada. The affected mattresses have two model numbers—REF P7924A01 and REF P7924ARENT01—with specific serial numbers listed in the recall documentation. A failure in these mattresses can reduce the performance of the Microclimate Management feature, which is designed to pull heat and moisture away from patients, potentially increasing the risk of pressure ulcer development.

The recall was issued due to the failure mode that compromises the mattress's ability to manage microclimate conditions effectively. The source document does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. 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 Lot/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,

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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