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

Baxter Healthcare Corporation: Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

Is my product affected?

Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

  • UPC 00887761977860

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

What happened

Baxter Healthcare Corporation is recalling Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattresses (model P3255A01) due to a failure mode that can reduce the performance of the Microclimate Management feature, which is designed to pull heat and moisture away from patients. This reduction in performance increases the risk of pressure ulcer development in patients using the affected mattresses. Eight mattresses have been identified with this issue, distributed nationwide across 28 U.S. states, Canada, and to government facilities.

The recalled mattresses are identified by UDI 00887761977860 and the following serial numbers: W214BP3955, W214BP3956, W243BP4436, W243BP4438, W243BP4445, W243BP4446, W243BP4447, and W243BP4448. The source document does not specify a remedy or instructions for affected consumers.

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: 8 mattresses Lot/code info: UDI 00887761977860, Serial numbers: W214BP3955, W214BP3956, W243BP4436, W243BP4438, W243BP4445, W243BP4446, W243BP4447, and W243BP4448.

Source

Official record: FDA (Device enforcement) ↗

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

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