Recall Z-2151-2024 ยท IOQ Bed, Flotation Therapy, Powered
Baxter Healthcare Corporation
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, R
| Date | Jun 14, 2024 (initiated May 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | 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 betw |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.