PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
Baxter Healthcare Corporation · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pr…
Open FDA's page for this record- Cfres ID
- 221960
- Product res number
- Z-3263-2026
- Event date initiated
- 2026-08-18
- Event date posted
- 2026-09-24
- Recall status
- Open, Classified
- Res event number
- 99606
- Product code
- IOQ
- Code info
- Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659
- Firm FEI number
- 1417572
- Recalling firm
- Baxter Healthcare Corporation
- Address 1
- 1 Baxter Pkwy
- City
- Deerfield
- State
- IL
- Postal code
- 60015-4625
- Additional info contact
- Center for One Baxter 1-847-9484770
- Root cause description
- Process control
- Product quantity
- 824 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Product description
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13
- Reason for recall
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
- Action
An "Urgent Medical Device Correction notification" letter dated 8/18/26 was sent to customers. Actions to be Taken by Customers 1.Locate the affected product at your facility and confirm each Product Code. Once product has been identified, use Hillrom pro+ Surface Instructions for Use (209196) (IFU) to assess the fit of the surfaces relative to the frame and siderails to confirm the surface is installed properly. If the surface does not meet the requirements set in the IFU please discontinue the use of this surface. 2. A Baxter representative will contact your facility to replace the incorrect label when it becomes available. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com even if you do not have any remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction. For general questions regarding this communication, please contact Baxter Global Technical Service at 800-445-3720 Option 2 between 8:00 am and 6:00 pm Eastern Time Monday through Friday.
- Harmonized identifiers (openFDA)
- Device name
- Bed, Flotation Therapy, Powered
- Medical specialty description
- Physical Medicine
- Regulation number
- 890.5170
- Device class
- 2
- K number
- K893614, K875321, K883192, K912855, K923977, K915671, K931594, K863047, K914674, K840882, K894723, K871368, K926189, K905053, K840881, K880486, K893708, K905126, K941610, K882229, K832829, K973624, K894353, K910851, K921768, K122473, K922973, K926456, K890935, K901295, K882177, K871614, K970295, K912854, K925694, K771264, K920382, K882607, K970364, K905156 +17 more
- Registration number
- 3014650138, 8043439, 1954156, 3017486514, 3011489684, 3007420694, 2032121, 3008058231, 3007309299, 3010010434, 3031218453, 8022290, 1824206, 2030595, 3003542872, 9710603, 3006697241, 2030732, 3036779619, 1931307, 1831750, 3012292104, 3009591865, 3007005431, 1834244
- FEI number
- 3014650138, 3017486514, 3011489684, 3007420694, 3008058231, 3007309299, 3010010434, 3031218453, 3000204953, 1824206, 3003542872, 3003083675, 3006697241, 3003513125, 3000040879, 3036779619, 1931307, 1000220700, 1831750, 3004411059, 3012292104, 3009591865, 3007005431, 1000518730, 3002693132