FDA Device recall Z-2151-2024
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat…
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat… by Baxter Healthcare, citing there is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2151-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-08 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) Centrella Max Surface, REF P7922A02; (3) Centrella Max Surface with X-Ray, REF P7922A03; (4) Centrella Max,Narrow, Rental, REF P7922ARENT01; (5) Centrella Pro+ 36" Surface with X-Ray, REF P7923A01; (6) Centrella Pro+ 40" Surface with X-Ray, REF P7923A02; (7) Centrella Pro+36" Surface, REF P7923A03; (8) Centrella Pro+ 40" Surface, REF P7923A04; (9) Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01; (10) 80" MRS with X-Ray AU/NZ REF P006800A03; (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01; (12) Pro+ MRS Surface for Versacare, REF P3255A02; (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01; (14) Pro+ 36"MRS Surface with X-Ray, REF P7924A01; (15) Pro+ 40" MRS Surface with X-Ray, REF P7924A02; (16) Pro+ 36" MRS Surface, REF P7924A03; (17) Pro+ 40" MRS Surface, REF P7924A04; (18) Pro+ 36" MRS Rental Surface with X-Ray, REF P7924ARENT01.
Reason
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Identifiers
| code_info | 1. REF P7922A01 - UDI-DI 887761999084; 2. REF P7922A02 - UDI-DI 887761999077; 3. REF P7922A03 - UDI-DI 887761984639;…1. REF P7922A01 - UDI-DI 887761999084; 2. REF P7922A02 - UDI-DI 887761999077; 3. REF P7922A03 - UDI-DI 887761984639; 4. REF P7922ARENT01 - UDI-DI 887761976962; 5. REF P7923A01 - UDI-DI 887761977945; 6. REF P7923A02 UDI-DI 887761977938; 7. REF P7923A03 UDI-DI 887761977921; 8. REF P7923A04 UDI-DI 887761977914; 9. REF P006800A01 - UDI-DI 887761977846; 10. REF P006800A03 - UDI-DI 887761955035; 11. REF P3255A01 - UDI-DI 887761977860; 12. REF P3255A02 UDI-DI 887761977853; 13. REF P3255ARENT01 UDI-DI 887761976887; 14. REF P7924A01 -UDI-DI 887761977907; 15. REF P7924A02 - UDI-DI 887761977891; 16. REF P7924A03 - UDI-DI 887761977884; 17. REF P7924A04 - UDI-DI 887761977877; 18. REF P7924ARENT01 - UDI-DI 887761976863. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2151-2024%22
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