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

Baxter Healthcare Corporation: Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.

Is my product affected?

Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.

  • UPC 00887761977921

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

What happened

Baxter Healthcare Corporation is recalling 70 Hill-Rom Centrella Pro+ 36" Surface mattresses (model REF P7923A03) due to a failure mode that can reduce performance of the Microclimate Management feature, which is designed to pull heat and moisture away from patients. This reduced performance increases patient risk of pressure ulcer development. The affected mattresses have been distributed worldwide, including to locations in 28 U.S. states, Canada, and to government facilities (but not military distribution).

The affected mattresses can be identified by UDI 00887761977921 and specific serial numbers beginning with W217BP, W228BP, X012BP, and X013BP. The recall record does not specify a remedy or action that 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: 70 mattresses Lot/code info: UDI 00887761977921; Serial numbers: W217BP4016, W217BP4039, W217BP4040, W228BP4177, W228BP4179, W228BP4180, W228BP4189, W228BP4190, W228BP4193, W228BP4194, W228BP4195, W228BP4198, W228BP4199, W228BP4201, W217BP4014, W217BP4015, W217BP4018, W217BP4019, W217BP4024, W217BP4025, W217BP4026, W217BP4027, W217BP4037, W217BP4038, W228BP4173, W228BP4174, W228BP4175, W228BP4185, W228BP4186, W228BP4188, W228BP4196, W228BP4200, W217BP4017, W217BP4020, W217BP4021, W217BP4022, W217BP4023, W217BP4028, W217BP4029, W217BP4030, W217BP4031, W217BP4032, W217BP4033, W217BP4034, W217BP4035, W217BP4036, W228BP4183, W228BP4184, W228BP4191, X012BP7192, X012BP7193, X012BP7194, X012BP7195, X012BP7198, X012BP7199, X012BP7202, X012BP7203, X012BP7204, X012BP7205,X012BP7206, X012BP7207, X012BP7208, X012BP7209, X012BP7210, X012BP7215, X013BP7238, X013BP7239, X013BP7240, X013BP7241, and X013BP7243.

Source

Official record: FDA (Device enforcement) ↗

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

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