Z-1416-2022Class II

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

Name: Z-1416-2022 Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03
Creator: Baxter Healthcare Corporation
Published: 2022-06-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03 on 2022-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1416-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-07-20
Recalling firm: Baxter Healthcare Corporation
Product: Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Product code: IOQ Bed, Flotation Therapy, Powered
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 70 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1416-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1411-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1412-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1413-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1414-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1415-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1416-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20
Z-1417-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code IOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)