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U.S. Department of Health and Human Services

Class 2 Device Recall Centrella Max and pro

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 Class 2 Device Recall Centrella Max and prosee related information
Date Initiated by FirmMay 08, 2024
Date PostedJune 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2151-2024
Recall Event ID 94600
Product Classification Bed, flotation therapy, powered - Product Code IOQ
ProductCentrella 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Error in labeling
ActionThe 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
Quantity in Commerce38,136 mattress units and 20,187 service part units
DistributionDistribution 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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