Hospital bed mattress covers may delaminate from improper cleaning
Baxter Healthcare is recalling Centrella Max and Pro+ hospital bed mattresses that may develop delaminated top covers when cleaned with bleach-containing solutions. The mattresses prevent and treat pressure injuries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall affecting a critical patient support system. Although no illnesses or injuries have been reported, mattress delamination compromises the product's intended function of preventing and treating pressure injuries in vulnerable hospital patients.
Plain-English summary
Baxter Healthcare Corporation is recalling multiple models of Centrella Max and Pro+ hospital bed mattresses. The mattress top covers can delaminate (separate or peel away) from the underlying structure.
The delamination occurs as a result of improper cleaning and inadequate information about the correct cleaning agents to use. Cleaning agents containing bleach can cause this damage, but users may not have had clear guidance on this restriction.
The recall affects 38,136 mattress units and 20,187 service parts. The mattresses were distributed nationwide in the United States, to military and government facilities, and internationally to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapore, Taiwan, Turkey, and the United Arab Emirates.
The mattresses are used in healthcare environments as patient support systems to prevent and treat pressure injuries. Healthcare facilities should stop using affected units and contact Baxter Healthcare for instructions on replacement or repair.
The recalled product
- 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)…
- Manufacturer
- Baxter Healthcare Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
Distributed nationwide across the United States.
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