Baxter Healthcare Corporation: Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.

Recall number

Z-1414-2022

Recalling firm

Baxter Healthcare Corporation

Product

Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.

Status

Open, Classified

Initiated

2022-06-24

Posted

not on file

Terminated

not on file

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.

Root cause

Nonconforming Material/Component

Action

The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. Distributors were instructed to share the notification with their end users. A response form was attached to be completed and returned within 2 weeks to confirm they have reviewed and understand the attached letter and that distributors have shared the notification with their end users and will complete the field action

Quantity

202 mattresses

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.

Lot, serial or model codes

UDI 00887761977853; Serial numbers: W236BP4315, W236BP4320, W236BP4326, W235BP4284, W235BP4294, W236BP4318, W236BP4319, W236BP4323, W236BP4325, W236BP4331, W236BP4333, W236BP4334, W236BP4336, W235BP4270, W235BP4271, W235BP4272, W235BP4278, W235BP4279, W235BP4287, W235BP4291, W235BP4292, W235BP4299, W235BP4307, W235BP4311, W236BP4314, W236BP4321, W236BP4322, W236BP4324, W236BP4329, W236BP4335, W235BP4309, W235BP4313, W215BP3994, W215BP3995, W215BP4002, W215BP4009, W215BP4011, W214BP3979, W214BP3980, W214BP3981, W214BP3982, W214BP3983, W215BP3985, W215BP3986, W215BP3990, W215BP3992, W215BP3993, W215BP3984, W215BP3987, W215BP3988, W215BP3989, W215BP3991, W215BP3996, W215BP4001, W215BP4003, W215BP4005, W215BP4006, W235BP4282, W235BP4285, W235BP4286, W235BP4289, W235BP4293, W235BP4295, W235BP4298, W235BP4300, W235BP4301, W235BP4302, W235BP4303, W235BP4304, W235BP4305, W235BP4306, W235BP4308, W236BP4316, W236BP4317, W236BP4327, W236BP4328, W236BP4330, W236BP4337, W214BP3968, W214BP3969, W214BP3970, W214BP3971, W214BP3972, W214BP3973, W214BP3974, W214BP3975, W214BP3976, W214BP3977, W214BP3978, W215BP3997, W215BP3998, W215BP3999, W215BP4000, W215BP4004, W215BP4007, W215BP4008, W215BP4010, W215BP4012, W235BP4267, W235BP4268, W235BP4269, W235BP4273, W235BP4275, W235BP4276, W235BP4277, W235BP4283, W344BP6702, W344BP6703, W344BP6727, W344BP6728, W344BP6729, W348BP6805, W348BP6806, W348BP6807, W348BP6812, W348BP6813, W348BP6820, W348BP6821, W348BP6827, W348BP6828, W348BP6830, W344BP6688, W344BP6690, W344BP6694, W344BP6695, W344BP6706, W344BP6707, W344BP6708, W344BP6709, W344BP6710, W344BP6713, W344BP6748, W347BP6776, W347BP6777, W347BP6787, W347BP6788, W347BP6789, W348BP6809, W348BP6810, W348BP6811, W348BP6814, W348BP6815, W348BP6816, W348BP6817, W348BP6818, W348BP6819, W348BP6826, W344BP6704, W344BP6705, W344BP6749, W344BP6689, W344BP6692, W344BP6698, W344BP6700, W344BP6701, W347BP6778, W347BP6781, W347BP6782, W347BP6783, W347BP6790, W347BP6791, W347BP6792, W347BP6802, W347BP6803, W348BP6823, W348BP6825, X048BP7395, X048BP7382, X048BP7383, X048BP7385, X048BP7386, X048BP7387, X048BP7388, X048BP7392, X048BP7394, X048BP7396, X048BP7397, X049BP7411, X049BP7412, X049BP7414, X049BP7415, X049BP7416, X049BP7418, X049BP7419, X049BP7420, X049BP7421, X049BP7422, X049BP7423, X049BP7424, X049BP7425, X055BP7466, X055BP7467, X055BP7469, X055BP7471, X055BP7473, X055BP7475, X055BP7476, X055BP7477, W348BP6824, W348BP6831, X048BP7384, and X048BP7391.

510(k) numbers

not on file

PMA numbers

not on file

Product code

IOQ

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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