—#207675

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.

FDA product code: IOQ — Bed, Flotation Therapy, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

The recalling firm issued letters on and dated 5/8/2024 via first class mail. The letter described the problem, listed the affected products, the hazard involved, and the actions to be taken by the customers. The actions informed the consignee of the following: (1) If bleach is occasionally used (for example as a disinfection against Clostridium difficile), remove any disinfectant residue prior to and after the use of bleach with a new or clean cloth soaked in tap water. Ensure all staff are trained in the protocol for the use of bleach during daily cleaning and as part of reprocessing between patients, by not using bleach as your primary cleaner/disinfectant. (2) If you have the affected product, identify if the top cover is damaged by examining for signs of abrasions, cuts, tears, or fluid ingress. Photographs are embedded in the letter showing a top cover with no damage and a top cover with damage. If top cover damage is identified, discontinue the use of that mattress. If damage is due to the use of bleach, a replacement will be arranged per step 3 below. (3) Contact Baxter Healthcare Center for Service to report any damaged or delaminated mattress covers. The phone number is provided and the hours of operation. (4) 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. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgment, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. (5) If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. I

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Distribution was made nationwide. There was also government/military distribution. Foreign distribution was made to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapore, Taiwan, Turkey, and United Arab Emirates.

Timeline

Recall initiated: 2024-05-08
Posted by FDA: 2024-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207675. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.