Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-R
Summary
The FDA issued a Class II for Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924A by Baxter Healthcare Corporation. 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 mois.
Details
Source
Device Recall
External ID
Z-1411-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
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, 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.
Quantity Affected: 200 mattresses
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1411-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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