Centrella Max - The Centrella Smart+ Bed is intended recall
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure…
Why was Centrella Max - The Centrella Smart+ Bed is intended 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 38,136 mattress units and 20,187 service part units
- Distribution
- 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.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)